510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-1489-2022Class I

Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR...

Medtronic, Inc. / initiated 2022-06-22 / Open, Classified / root cause: design
FDA source (opens on fda.gov)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4 on . FDA classified it as Class I and gives the reason as "There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-1489-2022
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
Medtronic, Inc.
Product
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
Product code
NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Reason for recall
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Root cause tag
design
FDA root cause
Device Design
Action
Beginning 22-JUN-2022 communications to all affected consignees began. In the United States notifications are sent via UPS 2-day delivery. For outside U.S. countries, notifications are handled via a regionally approved method. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification. Consignees are asked to quarantine the subset of unused identified Cobalt and Crome devices for retrieval due to potential manufacturing non-conformance and return the inventory to Medtronic. On approximately 08/10/2022, Medtronic notified Risk Managers of the availability of a SW update and actions specific to update the SW on the SmartSync devices, that will in turn update the patient's implanted device during their next clinic visit. In addition, on this same date, a separate communication dated August 2022 is being sent to all affected Implanting Physicians notifying them that a SW update is available and recommended actions to correct this issue with their patient's implanted device. The second notification to physicians did not request returned confirmation.
Quantity in commerce
1657 units
Distribution
Worldwide Distribution
Product codes and lots
a. Model Numbers:  DVPC3D1:  GTIN 00763000178543, Serial Numbers: RSG600007S, RSG600008S, RSG600009S, RSG600010S, RSG600011S, RSG600012S, RSG600013S, RSG600014S, RSG600017S, RSG600018S, RSG600020S, RSG600022S, RSG600023S, RSG600024S, RSG600025S, RSG600026S, RSG600027S, RSG600028S, RSG600029S, RSG600030S, RSG600031S, RSG600033S, RSG600036S, RSG600039S, RSG600040S, RSG600041S, RSG600042S, RSG600043S, RSG600045S, RSG600047S, RSG600049S, RSG600050S, RSG600052S, RSG600053S, RSG600054S, RSG600056S, RSG600057S, RSG600058S, RSG600059S, RSG600060S, RSG600063S, RSG600065S, RSG600066S, RSG600068S, RSG600070S, RSG600072S, RSG600073S, RSG600074S, RSG600075S, RSG600079S, RSG600084S, RSG600087S, RSG600088S, RSG600089S, RSG600098S, RSG600101S, RSG600103S, RSG600105S, RSG600305S, RSG600306S, RSG600310S, RSG600311S, RSG600313S, RSG600314S, RSG600315S, RSG600316S, RSG600317S, RSG600319S, RSG600320S, RSG600322S, RSG600324S, RSG600325S, RSG600327S, RSG600330S, RSG600332S, RSG600333S, RSG600334S, RSG600335S, RSG600337S, RSG600347S, RSG600348S, RSG600349S, RSG600350S, RSG600351S, RSG600352S, RSG600354S, RSG600355S, RSG600356S, RSG600357S, RSG600358S, RSG600359S, RSG600360S, RSG600361S, RSG600362S, RSG600363S, RSG600364S, RSG600365S, RSG600366S, RSG600367S, RSG600368S, RSG600370S, RSG600371S, RSG600374S, RSG600375S, RSG600376S, RSG600377S, RSG600379S, RSG600380S, RSG600382S, RSG600383S, RSG600384S, RSG600385S, RSG600386S, RSG600387S, RSG600388S, RSG600389S, RSG600390S, RSG600391S, RSG600392S, RSG600393S, RSG600394S, RSG600396S, RSG600397S, RSG600398S, RSG600399S, RSG600400S, RSG600401S, RSG600402S, RSG600403S, RSG600404S, RSG600405S, RSG600407S, RSG600408S, RSG600409S, RSG600410S, RSG600412S, RSG600413S, RSG600414S, RSG600415S, RSG600417S, RSG600418S, RSG600419S, RSG600420S, RSG600421S, RSG600422S, RSG600423S, RSG600424S, RSG600425S, RSG600426S, RSG600427S, RSG600428S, RSG600429S, RSG600430S, RSG600431S, RSG600432S, RSG600433S, RSG600434S, RSG600435S, RSG600436S, RSG600437S, RSG600438S, RSG600439S, RSG600440S, RSG600441S, RSG600442S, RSG600444S, RSG600445S, RSG600446S, RSG600447S, RSG600448S, RSG600449S, RSG600450S, RSG600451S, RSG600452S, RSG600453S, RSG600454S, RSG600456S, RSG600457S, RSG600458S, RSG600459S, RSG600460S, RSG600461S, RSG600462S, RSG600463S, RSG600464S, RSG600465S, RSG600466S, RSG600467S, RSG600469S, RSG600470S, RSG600471S, RSG600472S, RSG600474S, RSG600476S, RSG600478S, RSG600479S, RSG600480S, RSG600482S, RSG600485S; DVPC3D4:  GTIN 00763000178550, Serial Numbers: RSH600816S, RSH600826S, RSH600910S, RSH600917S GTIN 00763000178567, Serial Numbers: RSH600006S, RSH600008S, RSH600009S, RSH600011S, RSH600012S, RSH600015S, RSH600016S, RSH600017S, RSH600018S, RSH600019S, RSH600020S, RSH600021S, RSH600023S, RSH600024S, RSH600025S, RSH600027S, RSH600028S, RSH600029S, RSH600030S, RSH600032S, RSH600033S, RSH600034S, RSH600035S, RSH600185S, RSH600190S, RSH600200S, RSH600202S, RSH600206S, RSH600209S, RSH600210S, RSH600212S, RSH600213S, RSH600214S, RSH600217S, RSH600226S, RSH600227S, RSH600233S, RSH600237S, RSH600242S, RSH600243S, RSH600244S, RSH600245S, RSH600246S, RSH600247S, RSH600248S, RSH600252S, RSH600254S, RSH600255S, RSH600256S, RSH600269S, RSH600270S, RSH600271S, RSH600272S, RSH600273S, RSH600279S, RSH600283S, RSH600324S, RSH600354S, RSH600355S, RSH600357S, RSH600359S, RSH600362S, RSH600363S, RSH600368S, RSH600371S, RSH600373S, RSH600374S, RSH600376S, RSH600377S, RSH600378S, RSH600379S, RSH600380S, RSH600381S, RSH600382S, RSH600383S, RSH600384S, RSH600385S, RSH600388S, RSH600389S, RSH600390S, RSH600395S, RSH600396S, RSH600397S, RSH600398S, RSH600399S, RSH600400S, RSH600401S, RSH600402S, RSH600403S, RSH600404S, RSH600405S, RSH600406S, RSH600408S, RSH600409S, RSH600410S, RSH600411S, RSH600412S, RSH600413S, RSH600414S, RSH600415S, RSH600418S, RSH600419S, RSH600420S, RSH600421S, RSH600422S, RSH600423S, RSH600424S, RSH600425S, RSH600426S, RSH600428S, RSH600429S, RSH600430S, RSH600431S, RSH600432S, RSH600434S, RSH600435S, RSH600436S, RSH600437S, RSH600438S, RSH600440S, RSH600441S, RSH600443S, RSH600444S, RSH600445S, RSH600446S, RSH600447S, RSH600448S, RSH600449S, RSH600450S, RSH600451S, RSH600452S, RSH600453S, RSH600454S, RSH600455S, RSH600456S, RSH600457S, RSH600458S, RSH600459S, RSH600460S, RSH600461S, RSH600462S, RSH600463S, RSH600464S, RSH600465S, RSH600466S, RSH600467S, RSH600468S, RSH600469S, RSH600470S, RSH600471S, RSH600472S, RSH600473S, RSH600474S, RSH600475S, RSH600476S, RSH600477S, RSH600478S, RSH600479S, RSH600480S, RSH600481S, RSH600482S, RSH600483S, RSH600484S, RSH600485S, RSH600487S, RSH600488S, RSH600489S, RSH600490S, RSH600491S, RSH600493S, RSH600494S, RSH600495S, RSH600496S, RSH600497S, RSH600498S, RSH600499S, RSH600500S, RSH600501S, RSH600502S, RSH600503S, RSH600504S, RSH600505S, RSH600507S, RSH600508S, RSH600509S, RSH600529S, RSH600530S, RSH600531S, RSH600532S, RSH600533S, RSH600534S, RSH600535S, RSH600536S, RSH600537S, RSH600538S, RSH600539S, RSH600540S, RSH600541S, RSH600542S, RSH600543S, RSH600544S, RSH600545S, RSH600546S, RSH600547S, RSH600548S, RSH600549S, RSH600550S, RSH600551S, RSH600552S, RSH600553S, RSH600554S, RSH600555S, RSH600556S, RSH600557S, RSH600558S, RSH600559S, RSH600560S, RSH600561S, RSH600562S, RSH600563S, RSH600564S, RSH600565S, RSH600566S, RSH600567S, RSH600568S, RSH600569S, RSH600571S, RSH600572S, RSH600573S, RSH600574S, RSH600575S, RSH600576S, RSH600577S, RSH600578S, RSH600579S, RSH600580S, RSH600581S, RSH600582S, RSH600583S, RSH600584S, RSH600585S, RSH600586S, RSH600587S, RSH600588S, RSH600589S, RSH600590S, RSH600591S, RSH600592S, RSH600593S, RSH600594S, RSH600596S, RSH600597S, RSH600598S, RSH600599S, RSH600600S, RSH600601S, RSH600602S, RSH600603S, RSH600604S, RSH600605S, RSH600606S, RSH600607S, RSH600608S, RSH600609S, RSH600610S, RSH600612S, RSH600613S, RSH600614S, RSH600615S, RSH600616S, RSH600618S, RSH600619S, RSH600620S, RSH600622S, RSH600623S, RSH600624S, RSH600625S, RSH600626S, RSH600627S, RSH600629S, RSH600630S, RSH600631S, RSH600632S, RSH600633S, RSH600634S, RSH600635S, RSH600636S, RSH600637S, RSH600638S, RSH600639S, RSH600640S, RSH600641S, RSH600642S, RSH600643S, RSH600644S, RSH600645S, RSH600646S, RSH600647S, RSH600648S, RSH600649S, RSH600650S, RSH600651S, RSH600652S, RSH600653S, RSH600654S, RSH600655S, RSH600656S, RSH600657S, RSH600658S, RSH600659S, RSH600660S, RSH600662S, RSH600663S, RSH600664S, RSH600665S, RSH600666S, RSH600667S, RSH600668S, RSH600669S, RSH600670S, RSH600671S, RSH600672S, RSH600673S, RSH600674S, RSH600675S, RSH600676S, RSH600677S, RSH600678S, RSH600679S, RSH600680S, RSH600681S, RSH600682S, RSH600683S, RSH600684S, RSH600685S, RSH600686S, RSH600687S, RSH600688S, RSH600689S, RSH600690S, RSH600692S, RSH600693S, RSH600694S, RSH600695S, RSH600696S, RSH600697S, RSH600698S, RSH600699S, RSH600700S, RSH600701S, RSH600702S, RSH600703S, RSH600704S, RSH600705S, RSH600706S, RSH600708S, RSH600709S, RSH600710S, RSH600711S, RSH600713S, RSH600714S, RSH600715S, RSH600716S, RSH600717S, RSH600718S, RSH600719S, RSH600720S, RSH600721S, RSH600722S, RSH600723S, RSH600724S, RSH600725S, RSH600726S, RSH600727S, RSH600728S, RSH600729S, RSH600730S, RSH600731S, RSH600732S, RSH600733S, RSH600734S, RSH600735S, RSH600736S, RSH600737S, RSH600738S, RSH600739S, RSH600740S, RSH600741S, RSH600742S, RSH600743S, RSH600744S, RSH600745S, RSH600746S, RSH600747S, RSH600748S, RSH600749S, RSH600750S, RSH600751S, RSH600752S, RSH600753S, RSH600754S, RSH600755S, RSH600756S, RSH600757S, RSH600758S, RSH600759S, RSH600760S, RSH600761S, RSH600762S, RSH600763S, RSH600764S, RSH600765S, RSH600766S, RSH600767S, RSH600768S, RSH600769S, RSH600770S, RSH600771S, RSH600772S, RSH600773S, RSH600774S, RSH600775S, RSH600776S, RSH600777S, RSH600778S, RSH600779S, RSH600780S, RSH600781S, RSH600782S, RSH600783S, RSH600784S, RSH600785S, RSH600786S, RSH600787S, RSH600788S, RSH600789S, RSH600791S, RSH600792S, RSH600793S, RSH600794S, RSH600795S, RSH600796S, RSH600797S, RSH600798S, RSH600799S, RSH600800S, RSH600801S, RSH600803S, RSH600804S, RSH600805S, RSH600806S, RSH600807S, RSH600808S, RSH600809S, RSH600810S, RSH600811S, RSH600812S, RSH600813S, RSH600817S, RSH600834S, RSH600835S, RSH600836S, RSH600837S, RSH600838S, RSH600839S, RSH600840S, RSH600841S, RSH600842S, RSH600843S, RSH600844S, RSH600845S, RSH600846S, RSH600847S, RSH600848S, RSH600850S, RSH600851S, RSH600852S, RSH600853S, RSH600854S, RSH600855S, RSH600856S, RSH600857S, RSH600858S, RSH600859S, RSH600860S, RSH600861S, RSH600862S, RSH600863S, RSH600864S, RSH600865S, RSH600866S, RSH600867S, RSH600868S, RSH600869S, RSH600870S, RSH600871S, RSH600872S, RSH600873S, RSH600874S, RSH600875S, RSH600876S, RSH600877S, RSH600878S, RSH600880S, RSH600881S, RSH600883S, RSH600884S, RSH600885S, RSH600886S, RSH600888S, RSH600890S, RSH600892S, RSH600893S, RSH600894S, RSH600896S, RSH600897S, RSH600898S, RSH600899S, RSH600900S, RSH600904S, RSH600905S, RSH600909S, RSH600913S, RSH600914S, RSH600915S, RSH600916S, RSH600918S, RSH600923S, RSH600925S, RSH600926S, RSH600927S, RSH600928S, RSH600929S, RSH600930S, RSH600931S, RSH600932S, RSH600933S, RSH600934S, RSH600935S, RSH600936S, RSH600937S, RSH600938S, RSH600939S, RSH600940S, RSH600941S, RSH600942S, RSH600943S, RSH600944S, RSH600945S, RSH600946S, RSH600947S, RSH600948S, RSH600949S, RSH600952S, RSH600953S, RSH600954S, RSH600955S, RSH600956S, RSH600957S, RSH600958S, RSH600959S, RSH600961S, RSH600962S, RSH600963S, RSH600964S, RSH600965S, RSH600966S, RSH600967S, RSH600969S, RSH600970S, RSH600971S, RSH600972S, RSH600973S, RSH600974S, RSH600976S, RSH600977S, RSH600978S, RSH600979S, RSH600980S, RSH600981S, RSH600982S, RSH600983S, RSH600984S, RSH600985S, RSH600986S, RSH600987S, RSH600988S, RSH600989S, RSH600990S, RSH600991S, RSH600992S, RSH600993S, RSH600994S, RSH600995S, RSH600996S, RSH600997S, RSH600998S, RSH600999S, RSH601000S, RSH601001S, RSH601002S, RSH601003S, RSH601004S, RSH601005S, RSH601006S, RSH601007S, RSH601008S, RSH601009S, RSH601010S, RSH601011S, RSH601012S, RSH601013S, RSH601015S, RSH601016S, RSH601017S, RSH601018S, RSH601019S, RSH601020S, RSH601040S, RSH601042S, RSH601043S, RSH601044S, RSH601045S, RSH601046S, RSH601047S, RSH601048S, RSH601049S, RSH601050S, RSH601053S, RSH601054S, RSH601055S, RSH601056S, RSH601057S, RSH601059S, RSH601060S, RSH601061S, RSH601066S, RSH601067S, RSH601069S, RSH601070S, RSH601071S, RSH601072S, RSH601073S, RSH601074S, RSH601077S, RSH601078S, RSH601079S, RSH601080S, RSH601081S, RSH601082S, RSH601083S, RSH601084S, RSH601085S, RSH601086S, RSH601087S, RSH601088S, RSH601089S, RSH601090S, RSH601091S, RSH601092S, RSH601094S, RSH601095S, RSH601097S, RSH601099S, RSH601100S, RSH601101S, RSH601102S, RSH601103S, RSH601111S, RSH601112S, RSH601114S, RSH601116S, RSH601119S, RSH601120S, RSH601128S, RSH601141S, RSH601142S, RSH601143S, RSH601144S, RSH601145S, RSH601146S, RSH601153S, RSH601154S, RSH601155S, RSH601156S, RSH601158S, RSH601159S, RSH601160S, RSH601161S, RSH601162S, RSH601163S, RSH601164S, RSH601165S, RSH601166S, RSH601167S, RSH601168S, RSH601169S, RSH601170S, RSH601171S, RSH601172S, RSH601173S, RSH601174S, RSH601175S, RSH601176S, RSH601177S, RSH601178S, RSH601179S, RSH601180S;  b. Model Numbers:  DDPC3D1:  GTIN 00763000178413, Serial Numbers: RSP600136S, RSP600141S, RSP600386S;  GTIN 00763000178420, Serial Numbers: RSP600027S, RSP600034S, RSP600041S, RSP600056S, RSP600061S, RSP600064S, RSP600077S, RSP600100S, RSP600125S, RSP600143S, RSP600151S, RSP600155S, RSP600165S, RSP600171S, RSP600172S, RSP600179S, RSP600401S, RSP600414S, RSP600508S, RSP600510S, RSP600511S, RSP600512S, RSP600513S, RSP600515S, RSP600516S, RSP600517S, RSP600519S, RSP600520S, RSP600521S, RSP600522S, RSP600523S, RSP600524S, RSP600525S, RSP600526S, RSP600528S, RSP600531S, RSP600533S, RSP600536S, RSP600537S, RSP600538S, RSP600540S, RSP600542S, RSP600543S, RSP600546S, RSP600547S, RSP600549S, RSP600550S, RSP600552S, RSP600553S, RSP600554S, RSP600555S, RSP600556S, RSP600557S, RSP600559S, RSP600560S, RSP600561S, RSP600563S, RSP600564S, RSP600565S, RSP600567S, RSP600574S, RSP600575S, RSP600577S, RSP600579S, RSP600588S, RSP600590S, RSP600591S, RSP600592S, RSP600593S, RSP600594S, RSP600595S, RSP600596S, RSP600597S, RSP600598S, RSP600599S, RSP600600S, RSP600601S, RSP600603S, RSP600604S, RSP600606S, RSP600607S, RSP600609S, RSP600610S, RSP600612S, RSP600613S, RSP600614S, RSP600615S, RSP600616S, RSP600617S, RSP600618S, RSP600619S, RSP600620S, RSP600621S, RSP600622S, RSP600623S, RSP600624S, RSP600625S, RSP600626S, RSP600627S, RSP600628S, RSP600630S, RSP600632S, RSP600633S, RSP600634S, RSP600635S, RSP600636S, RSP600638S, RSP600639S, RSP600640S, RSP600641S, RSP600642S, RSP600643S, RSP600644S, RSP600646S, RSP600649S, RSP600650S, RSP600651S, RSP600653S, RSP600655S, RSP600656S, RSP600657S, RSP600658S, RSP600659S, RSP600660S, RSP600661S, RSP600662S, RSP600663S, RSP600664S, RSP600665S, RSP600666S, RSP600667S, RSP600668S, RSP600669S, RSP600670S, RSP600671S, RSP600672S, RSP600673S, RSP600674S, RSP600675S, RSP600676S, RSP600677S, RSP600678S, RSP600679S, RSP600680S, RSP600681S, RSP600682S, RSP600683S, RSP600684S, RSP600685S, RSP600686S, RSP600687S, RSP600689S, RSP600690S, RSP600691S, RSP600692S, RSP600693S, RSP600694S, RSP600695S, RSP600701S;  DDPC3D4:  GTIN 00763000178437, Serial Numbers: RSQ600232S, RSQ600677S, RSQ600735S, RSQ600777S, RSQ600783S, RSQ600801S, RSQ600820S, RSQ600824S, RSQ600916S, RSQ600981S, RSQ601103S, RSQ601172S; GTIN 00763000178444, Serial Numbers: RSQ600006S, RSQ600007S, RSQ600008S, RSQ600009S, RSQ600010S, RSQ600011S, RSQ600013S, RSQ600014S, RSQ600015S, RSQ600018S, RSQ600019S, RSQ600020S, RSQ600022S, RSQ600023S, RSQ600024S, RSQ600026S, RSQ600027S, RSQ600030S, RSQ600031S, RSQ600032S, RSQ600034S, RSQ600037S, RSQ600038S, RSQ600039S, RSQ600040S, RSQ600041S, RSQ600042S, RSQ600044S, RSQ600045S, RSQ600046S, RSQ600047S, RSQ600187S, RSQ600189S, RSQ600190S, RSQ600193S, RSQ600196S, RSQ600198S, RSQ600203S, RSQ600206S, RSQ600215S, RSQ600217S, RSQ600230S, RSQ600234S, RSQ600250S, RSQ600260S, RSQ600264S, RSQ600281S, RSQ600287S, RSQ600290S, RSQ600294S, RSQ600295S, RSQ600297S, RSQ600340S, RSQ600364S, RSQ600365S, RSQ600366S, RSQ600367S, RSQ600368S, RSQ600369S, RSQ600370S, RSQ600371S, RSQ600372S, RSQ600373S, RSQ600376S, RSQ600377S, RSQ600378S, RSQ600379S, RSQ600380S, RSQ600381S, RSQ600382S, RSQ600383S, RSQ600384S, RSQ600385S, RSQ600386S, RSQ600387S, RSQ600388S, RSQ600390S, RSQ600391S, RSQ600392S, RSQ600393S, RSQ600394S, RSQ600395S, RSQ600396S, RSQ600397S, RSQ600398S, RSQ600399S, RSQ600400S, RSQ600401S, RSQ600402S, RSQ600403S, RSQ600404S, RSQ600405S, RSQ600406S, RSQ600407S, RSQ600408S, RSQ600409S, RSQ600410S, RSQ600411S, RSQ600412S, RSQ600413S, RSQ600414S, RSQ600433S, RSQ600434S, RSQ600435S, RSQ600437S, RSQ600438S, RSQ600439S, RSQ600440S, RSQ600441S, RSQ600442S, RSQ600443S, RSQ600444S, RSQ600445S, RSQ600446S, RSQ600447S, RSQ600448S, RSQ600449S, RSQ600450S, RSQ600451S, RSQ600452S, RSQ600453S, RSQ600454S, RSQ600455S, RSQ600456S, RSQ600457S, RSQ600458S, RSQ600459S, RSQ600461S, RSQ600462S, RSQ600463S, RSQ600464S, RSQ600466S, RSQ600467S, RSQ600468S, RSQ600469S, RSQ600470S, RSQ600471S, RSQ600472S, RSQ600473S, RSQ600474S, RSQ600475S, RSQ600476S, RSQ600477S, RSQ600479S, RSQ600480S, RSQ600482S, RSQ600483S, RSQ600484S, RSQ600485S, RSQ600486S, RSQ600487S, RSQ600488S, RSQ600489S, RSQ600490S, RSQ600491S, RSQ600492S, RSQ600493S, RSQ600494S, RSQ600495S, RSQ600496S, RSQ600497S, RSQ600498S, RSQ600499S, RSQ600500S, RSQ600501S, RSQ600502S, RSQ600503S, RSQ600504S, RSQ600505S, RSQ600506S, RSQ600507S, RSQ600508S, RSQ600509S, RSQ600510S, RSQ600511S, RSQ600512S, RSQ600513S, RSQ600514S, RSQ600515S, RSQ600516S, RSQ600517S, RSQ600518S, RSQ600519S, RSQ600520S, RSQ600521S, RSQ600522S, RSQ600523S, RSQ600524S, RSQ600525S, RSQ600526S, RSQ600527S, RSQ600528S, RSQ600529S, RSQ600530S, RSQ600531S, RSQ600532S, RSQ600533S, RSQ600534S, RSQ600535S, RSQ600536S, RSQ600537S, RSQ600538S, RSQ600539S, RSQ600540S, RSQ600541S, RSQ600542S, RSQ600543S, RSQ600544S, RSQ600545S, RSQ600546S, RSQ600547S, RSQ600548S, RSQ600549S, RSQ600550S, RSQ600551S, RSQ600552S, RSQ600553S, RSQ600554S, RSQ600555S, RSQ600557S, RSQ600558S, RSQ600560S, RSQ600561S, RSQ600562S, RSQ600563S, RSQ600564S, RSQ600565S, RSQ600567S, RSQ600572S, RSQ600574S, RSQ600575S, RSQ600577S, RSQ600578S, RSQ600579S, RSQ600580S, RSQ600581S, RSQ600582S, RSQ600583S, RSQ600584S, RSQ600585S, RSQ600586S, RSQ600587S, RSQ600588S, RSQ600589S, RSQ600590S, RSQ600592S, RSQ600593S, RSQ600594S, RSQ600596S, RSQ600597S, RSQ600598S, RSQ600599S, RSQ600600S, RSQ600603S, RSQ600604S, RSQ600605S, RSQ600608S, RSQ600609S, RSQ600612S, RSQ600613S, RSQ600614S, RSQ600615S, RSQ600616S, RSQ600617S, RSQ600618S, RSQ600619S, RSQ600620S, RSQ600622S, RSQ600623S, RSQ600624S, RSQ600625S, RSQ600626S, RSQ600628S, RSQ600629S, RSQ600630S, RSQ600632S, RSQ600634S, RSQ600635S, RSQ600636S, RSQ600637S, RSQ600638S, RSQ600639S, RSQ600640S, RSQ600642S, RSQ600643S, RSQ600644S, RSQ600646S, RSQ600647S, RSQ600649S, RSQ600650S, RSQ600651S, RSQ600652S, RSQ600653S, RSQ600654S, RSQ600655S, RSQ600659S, RSQ600661S, RSQ600662S, RSQ600663S, RSQ600664S, RSQ600669S, RSQ600671S, RSQ600672S, RSQ600673S, RSQ600674S, RSQ600676S, RSQ600680S, RSQ600681S, RSQ600682S, RSQ600684S, RSQ600686S, RSQ600687S, RSQ600688S, RSQ600689S, RSQ600690S, RSQ600692S, RSQ600696S, RSQ600697S, RSQ600699S, RSQ600706S, RSQ600707S, RSQ600708S, RSQ600711S, RSQ600714S, RSQ600715S, RSQ600722S, RSQ600724S, RSQ600725S, RSQ600727S, RSQ600730S, RSQ600731S, RSQ600784S, RSQ600792S, RSQ600805S, RSQ600806S, RSQ600810S, RSQ600818S, RSQ600825S, RSQ600826S, RSQ600832S, RSQ600833S, RSQ600834S, RSQ600835S, RSQ600838S, RSQ600839S, RSQ600840S, RSQ600841S, RSQ600844S, RSQ600845S, RSQ600846S, RSQ600847S, RSQ600848S, RSQ600849S, RSQ600850S, RSQ600851S, RSQ600852S, RSQ600853S, RSQ600855S, RSQ600856S, RSQ600857S, RSQ600861S, RSQ600862S, RSQ600863S, RSQ600864S, RSQ600865S, RSQ600866S, RSQ600867S, RSQ600868S, RSQ600869S, RSQ600870S, RSQ600871S, RSQ600872S, RSQ600873S, RSQ600874S, RSQ600875S, RSQ600876S, RSQ600878S, RSQ600879S, RSQ600880S, RSQ600881S, RSQ600882S, RSQ600883S, RSQ600884S, RSQ600886S, RSQ600887S, RSQ600888S, RSQ600889S, RSQ600892S, RSQ600893S, RSQ600898S, RSQ600901S, RSQ600902S, RSQ600909S, RSQ600925S, RSQ600926S, RSQ600947S, RSQ600950S, RSQ600953S, RSQ600955S, RSQ600956S, RSQ600961S, RSQ600962S, RSQ600963S, RSQ600964S, RSQ600965S, RSQ600967S, RSQ600999S, RSQ601003S, RSQ601005S, RSQ601009S, RSQ601011S, RSQ601012S, RSQ601013S, RSQ601016S, RSQ601017S, RSQ601018S, RSQ601019S, RSQ601020S, RSQ601021S, RSQ601022S, RSQ601023S, RSQ601024S, RSQ601025S, RSQ601027S, RSQ601029S, RSQ601030S, RSQ601031S, RSQ601032S, RSQ601033S, RSQ601034S, RSQ601035S, RSQ601036S, RSQ601037S, RSQ601038S, RSQ601039S, RSQ601040S, RSQ601041S, RSQ601042S, RSQ601043S, RSQ601044S, RSQ601045S, RSQ601046S, RSQ601047S, RSQ601048S, RSQ601049S, RSQ601050S, RSQ601051S, RSQ601052S, RSQ601053S, RSQ601054S, RSQ601055S, RSQ601056S, RSQ601057S, RSQ601058S, RSQ601059S, RSQ601060S, RSQ601061S, RSQ601062S, RSQ601064S, RSQ601065S, RSQ601066S, RSQ601067S, RSQ601068S, RSQ601069S, RSQ601070S, RSQ601072S, RSQ601074S, RSQ601075S, RSQ601076S, RSQ601077S, RSQ601079S, RSQ601080S, RSQ601081S, RSQ601082S, RSQ601083S, RSQ601084S, RSQ601085S, RSQ601087S, RSQ601088S, RSQ601089S, RSQ601091S, RSQ601093S, RSQ601095S, RSQ601098S, RSQ601099S, RSQ601100S, RSQ601102S, RSQ601104S, RSQ601105S, RSQ601106S, RSQ601107S, RSQ601109S, RSQ601111S, RSQ601112S, RSQ601113S, RSQ601114S, RSQ601115S, RSQ601116S, RSQ601117S, RSQ601118S, RSQ601119S, RSQ601120S, RSQ601121S, RSQ601123S, RSQ601124S, RSQ601125S, RSQ601126S, RSQ601127S, RSQ601128S, RSQ601129S, RSQ601130S, RSQ601131S, RSQ601133S, RSQ601136S, RSQ601139S, RSQ601140S, RSQ601141S, RSQ601142S, RSQ601143S, RSQ601144S, RSQ601145S, RSQ601146S, RSQ601149S, RSQ601171S, RSQ601173S, RSQ601180S, RSQ601184S, RSQ601187S, RSQ601195S, RSQ601197S, RSQ601198S, RSQ601199S, RSQ601200S, RSQ601202S, RSQ601204S, RSQ601206S, RSQ601207S, RSQ601209S, RSQ601213S, RSQ601230S, RSQ601231S, RSQ601232S, RSQ601233S, RSQ601235S, RSQ601236S, RSQ601237S, RSQ601238S, RSQ601245S, RSQ601246S, RSQ601251S, RSQ601253S, RSQ601255S, RSQ601261S, RSQ601262S, RSQ601263S, RSQ601268S, RSQ601269S, RSQ601275S, RSQ601276S, RSQ601280S, RSQ601281S, RSQ601283S, RSQ601284S, RSQ601286S, RSQ601291S, RSQ601295S, RSQ601301S, RSQ601302S, RSQ601303S, RSQ601304S, RSQ601305S, RSQ601311S.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1489-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1485-2022Class IOngoingVoluntary: Firm initiated
Z-1486-2022Class IOngoingVoluntary: Firm initiated
Z-1487-2022Class IOngoingVoluntary: Firm initiated
Z-1488-2022Class IOngoingVoluntary: Firm initiated
Z-1489-2022Class IOngoingVoluntary: Firm initiated
Z-1490-2022Class IOngoingVoluntary: Firm initiated