Z-1093-2023Class II
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-11-17 / Open, Classified / root cause: design
MEDLINE INDUSTRIES, LP - Northfield began a recall of Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR... on . FDA classified it as Class II and gives the reason as "Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1093-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTERECTOMY PACK-LF l. HYSTERECTOMY PACK m. MAJOR ABD PROCEDURE PACK-LF n. GYN PACK o. BLADDER SLING PACK p. PERI/GYN PACK-RFD q. ROBOT HYSTERECTOMY r. VAG HYST s. GYN MAJOR PACK t. VAGINAL HYSTER PROCEDURE u. TLH PACK v. TLH PACK w. VAG HYST PACK x. LITHOTOMY-LF y. MAJOR LITHOTOMY z. LAVH aa. LAVH bb. D&C / GYN cc. LAPAROSCOPIC HYSTERECTOMY dd. FS LAP TUBAL LIGATION ee. LAVH ff. ABD HYST PACK-LF gg. VAG HYST PK-LF
- Product code
- OJF Hysterectomy Kit
- Reason for recall
- Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.
- Quantity in commerce
- 1,258 cases (2,154 units)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
- Product codes and lots
- a. GYN ABD CDS, Item Number: CDS830215G, Case UDI/GTIN: 40889942110040, Unit UDI/GTIN: 10889942110049, Lot Number: 22IMD263; b. LAVH PROCEDURE, Item Number: CDS980754R, Case UDI/GTIN: 40195327008698, Unit UDI/GTIN: 10195327008697, Lot Number: 22JME637; c. TAH CDS, Item Number: CDS982249I, Case UDI/GTIN: 40193489651264, Unit UDI/GTIN: 10193489651263, Lot Number: 22JBM626,22JBK303; d. CUH LITHOTOMY CDS, Item Number: CDS983207M, Case UDI/GTIN: 40195327164608, Unit UDI/GTIN: 10195327164607, Lot Number: 22JBM359; e. LAVH CDS, Item Number: CDS983455C, Case UDI/GTIN: 40193489413114, Unit UDI/GTIN: 10193489413113, Lot Number: 22HBU206,22HBU964; f. GROTH VAGINAL CDS, Item Number: CDS984201T, Case UDI/GTIN: 40195327143986, Unit UDI/GTIN: 10195327143985, Lot Number: 22IBA054; g. MAJOR LITHOTOMY, Item Number: CDS985547N, Case UDI/GTIN: 40193489899925, Unit UDI/GTIN: 10193489899924, Lot Number: 22JBN433,22IBE548; h. MAJOR VAGINAL HARPER PACK-LF, Item Number: DYNJ0161768F, Case UDI/GTIN: 40195327171507, Unit UDI/GTIN: 10195327171506, Lot Number: 22IDC076,22IDA825,22IDA274; i. VAG. HYST TRAY-LF, Item Number: DYNJ0209066N, Case UDI/GTIN: 40889942054429, Unit UDI/GTIN: 10889942054428, Lot Number: 22JME324; j. VAGINAL HYSTERECTOMY PACK-LF, Item Number: DYNJ0373807K, Case UDI/GTIN: 40195327225682, Unit UDI/GTIN: 10195327225681, Lot Number: 22JBO175; k. HYSTERECTOMY PACK-LF, Item Number: DYNJ20485L, Case UDI/GTIN: 40195327024360, Unit UDI/GTIN: 10195327024369, Lot Number: 22IDA372; l. HYSTERECTOMY PACK, Item Number: DYNJ25971I, Case UDI/GTIN: 40888277763525, Unit UDI/GTIN: 10888277763524, Lot Number: 22JBO188; m. MAJOR ABD PROCEDURE PACK-LF, Item Number: DYNJ36731F, Case UDI/GTIN: 40195327148196, Unit UDI/GTIN: 10195327148195, Lot Number: 22IBA619; n. GYN PACK, Item Number: DYNJ40409C, Case UDI/GTIN: 40889942215929, Unit UDI/GTIN: 10889942215928, Lot Number: 22JBM950; o. BLADDER SLING PACK, Item Number: DYNJ43887, Case UDI/GTIN: 40888277073266, Unit UDI/GTIN: 10888277073265, Lot Number: 22JBN288,22IBD109; p. PERI/GYN PACK-RFD, Item Number: DYNJ48918J, Case UDI/GTIN: 40193489729994, Unit UDI/GTIN: 10193489729993, Lot Number: 22JMD314; q. ROBOT HYSTERECTOMY, Item Number: DYNJ49221C, Case UDI/GTIN: 40193489313766, Unit UDI/GTIN: 10193489313765, Lot Number: 22KMA208; r. VAG HYST, Item Number: DYNJ51386B, Case UDI/GTIN: 40193489944229, Unit UDI/GTIN: 10193489944228, Lot Number: 22IBJ500; s. GYN MAJOR PACK, Item Number: DYNJ52095I, Case UDI/GTIN: 40193489996945, Unit UDI/GTIN: 10193489996944, Lot Number: 22IDA203; t. VAGINAL HYSTER PROCEDURE, Item Number: DYNJ53804, Case UDI/GTIN: 40889942444602, Unit UDI/GTIN: 10889942444601, Lot Number: 22JDB955; u. TLH PACK, Item Number: DYNJ63145A, Case UDI/GTIN: 40193489979573, Unit UDI/GTIN: 10193489979572, Lot Number: 22JBN742,22IBK842; v. TLH PACK, Item Number: DYNJ80430, Case UDI/GTIN: 40195327038473, Unit UDI/GTIN: 10195327038472, Lot Number: 22HBN532; w. VAG HYST PACK, Item Number: DYNJ82634, Case UDI/GTIN: 40195327199563, Unit UDI/GTIN: 10195327199562, Lot Number: 22JBY522; x. LITHOTOMY-LF, Item Number: DYNJ900721C, Case UDI/GTIN: 40193489951609, Unit UDI/GTIN: 10193489951608, Lot Number: 22KBC673; y. MAJOR LITHOTOMY, Item Number: DYNJ902373I, Case UDI/GTIN: 40195327224760, Unit UDI/GTIN: 10195327224769, Lot Number: 22JBO747; z. LAVH, Item Number: DYNJ903392F, Case UDI/GTIN: 40193489467506, Unit UDI/GTIN: 10193489467505, Lot Number: 22JBR451; aa. LAVH, Item Number: DYNJ904335B, Case UDI/GTIN: 40193489926720, Unit UDI/GTIN: 10193489926729, Lot Number: 22JBU057; bb. D&C / GYN, Item Number: DYNJ906514B, Case UDI/GTIN: 40193489998567, Unit UDI/GTIN: 10193489998566, Lot Number: 22IBP589,22IBD796; cc. LAPAROSCOPIC HYSTERECTOMY, Item Number: DYNJ906844A, Case UDI/GTIN: 40195327025954, Unit UDI/GTIN: 10195327025953, Lot Number: 22JMG630; dd. FS LAP TUBAL LIGATION, Item Number: DYNJ908306, Case UDI/GTIN: 40195327030316, Unit UDI/GTIN: 10195327030315, Lot Number: 22KBE781,22JBO684; ee. LAVH, Item Number: DYNJQ9041Q, Case UDI/GTIN: 40193489850605, Unit UDI/GTIN: 10193489850604, Lot Number: 22JBG106,22IBB420,22IBC141; ff. ABD HYST PACK-LF, Item Number: DYNJT1912G, Case UDI/GTIN: 40888277809056, Unit UDI/GTIN: 10888277809055, Lot Number: 22HBW646; gg. VAG HYST PK-LF, Item Number: DYNJT1913J, Case UDI/GTIN: 40193489976473, Unit UDI/GTIN: 10193489976472, Lot Number: 22IBQ666,22HBU577
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1060-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1061-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1062-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1063-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1064-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1065-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1066-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1067-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1068-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1069-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1070-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1071-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1072-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1073-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1074-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1075-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1076-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1077-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1078-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1079-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1080-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1081-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1082-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1083-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1084-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1085-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1086-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1087-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1088-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1089-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1090-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1091-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1092-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1093-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1094-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1095-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1096-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1097-2023 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.