Z-2303-2023Class II
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-05-15 / Open, Classified / root cause: manufacturing process
MEDLINE INDUSTRIES, LP - Northfield began a recall of Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ22350K... on . FDA classified it as Class II and gives the reason as "Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2303-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ22350K, DYNJ22350L, DYNJ22676J, DYNJ23445F, DYNJ31902L, DYNJ31902M, DYNJ39432I, DYNJ39432J, DYNJ39432K, DYNJ41625B, DYNJ46246A, DYNJ53438A, DYNJ53610C, DYNJ53995G, DYNJ56791A, DYNJ56791B, DYNJ57490A, DYNJ58608, DYNJ58681A, DYNJ58681B, DYNJ58710, DYNJ61325A, DYNJ61325B, DYNJ61528, DYNJ62399A, DYNJ65160, DYNJ66356, DYNJ66356A, DYNJ66356B, DYNJ66356C, DYNJ66356D, DYNJ66577, DYNJ68492A, DYNJ68492B, DYNJ68492C, DYNJ68492D, DYNJ68863, DYNJ68863A, DYNJ68880, DYNJ80599, DYNJ81626, DYNJ82016, DYNJ82104, DYNJ82144, DYNJ82769, DYNJ82769A, DYNJ83146; b. VASCULAR PACK CHRG, Model Number: DYNJ59778A, DYNJ59778B; c. VASCULAR PACK GWV, Model Number: DYNJ59245; DYNJ59245A; d. VASCULAR PACK MH-LF, Model Number: DYNJ39866B, DYNJ39866C; e. VASCULAR PACK SHD, Model Number: DYNJ68404; f. VASCULAR PACK-LF, Model Number: DYNJ0250564O, DYNJ0250564P, DYNJ0373040N, DYNJ0493141G, DYNJ0493141I, DYNJ0493141J, DYNJ0871182AC, DYNJ0901358I, DYNJ0901358J, DYNJ0901358K, DYNJ53475F, DYNJ53684A, PHS400047N, PHS400047O; g. VASCULAR STENT INOVA, Model Number: DYNJ906440A; h. VASCULAR TRAY, Model Number: DYNJ56858; i. VASCULAR/OR ANGIO, Model Number: DYNJ905079F; j. VASCULAR-LF, Model Number: DYNJ900714B, DYNJ900714C; k. VEIN ABLATION EXCISION ASC, Model Number: DYNJ52586B; l. VEIN ABLATION & EXCISION ASC, Model Number: DYNJ52586, DYNJ52586A, DYNJ52586B; m. VEIN ABLATION KIT, Model Number: DYNJ69272A; n. VEIN ABLATION PACK, Model Number: DYNJ62889; o. VEIN ABLATION TRAY W/CHLOR, Model Number: DYNJ64396; p. VEIN AND LASER PACK, Model Number: DYNJ49874; q. VEIN CENTER PACK, Model Number: DYNJ52123; r. VEIN CLINIC, Model Number: DYNJ68667; s. VEIN CLOSURE PACK, Model Number: DYNJ35586G, DYNJ39408F, DYNJ65189B; t. VEIN CLOSURE TRAY, Model Number: DYNJ44737B; u. VEIN KIT, Model Number: DYNJ57047; v. VEIN LIGATION, Model Number: DYNJ64190; w. VEIN OHH, Model Number: DYNJ65560A; x. VEIN PACK, Model Number: DYNJ21949J, DYNJ39005B, DYNJ39889, DYNJ48493, DYNJ48907F, DYNJ50785, DYNJ52098, DYNJ52993A, DYNJ53160, DYNJ53160A, DYNJ54153B, DYNJ55268, DYNJ55462A, DYNJ55514A, DYNJ55849A, DYNJ56624, DYNJ56724A, DYNJ56724B, DYNJ57512, DYNJ57835, DYNJ57917, DYNJ58063, DYNJ58609, DYNJ59151F, DYNJ59662B, DYNJ59662D, DYNJ59677A, DYNJ59681A, DYNJ61540C, DYNJ63823, DYNJ64282, DYNJ64471A, DYNJ65579, DYNJ66154, DYNJ66743A, DYNJ68749, DYNJ69091, DYNJ80199A, DYNJ80199B, DYNJ80868, DYNJ83147; y. VEIN PACK II, Model Number: DYNJ66427; z. VEIN PACK-LF, Model Number: DYNJ66271A, DYNJ66271C; aa. VEIN PROCEDURE, Model Number: DYNJ65342A; bb. VEIN PROCEDURE PACK, Model Number: DYNJ38264D, DYNJ62038A, DYNJ64909; cc. VEIN SPECIALISTS PACK, Model Number: DYNJ53616A; dd. VEIN TRAY, Model Number: DYNJ57003, DYNJ62829A; ee. VENOUS ABLATION, Model Number: DYNJ50227C; ff. VENOUS ACCESS ACCESSORY PACK, Model Number: DYNJ61010A; gg. VENOUS ACCESS PACK, Model Number: DYNJ44421D; hh. VIRC STROKE PACK, Model Number: DYNJ83461; ii. VNUS, Model Number: CDS984292I; jj. VNUS CLOSURE, Model Number: DYNJ66076; kk. VNUS VASCULAR PACK, Model Number: DYNJ66445; ll. WA VASCULAR PACK-LF, Model Number: DYNJ33612G
- Product code
- OEZ Cardiovascular Procedure Kit
- Reason for recall
- Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- Medline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline. Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits.
- Quantity in commerce
- 100,549 kits
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
- Product codes and lots
- All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ22350K, UPC Number: 019348956435; Model Number: DYNJ22350L, UPC Number: 019348944525; Model Number: DYNJ22676J, UPC Number: 019348956435; Model Number: DYNJ23445F, UPC Number: 019532715035; Model Number: DYNJ31902L, UPC Number: 019348956435; Model Number: DYNJ31902M, UPC Number: 019532729658; Model Number: DYNJ39432I, UPC Number: 019348933454; Model Number: DYNJ39432J, UPC Number: 019532710115; Model Number: DYNJ39432K, UPC Number: 019532730509; Model Number: DYNJ41625B, UPC Number: 088994293420; Model Number: DYNJ46246A, UPC Number: 088994258496; Model Number: DYNJ53438A, UPC Number: 019348965302; Model Number: DYNJ53610C, UPC Number: 019348930032; Model Number: DYNJ53995G, UPC Number: 019532707376; Model Number: DYNJ56791A, UPC Number: 019348959411; Model Number: DYNJ56791B, UPC Number: 019532704567; Model Number: DYNJ57490A, UPC Number: 019348964199; Model Number: DYNJ58608, UPC Number: 088994287195; Model Number: DYNJ58681A, UPC Number: 088827779848; Model Number: DYNJ58681B, UPC Number: 019532729337; Model Number: DYNJ58710, UPC Number: 088994288085; Model Number: DYNJ61325A, UPC Number: 019348979445; Model Number: DYNJ61325B, UPC Number: 019532709784; Model Number: DYNJ61528, UPC Number: 019348957898; Model Number: DYNJ62399A, UPC Number: 019348925026; Model Number: DYNJ65160, UPC Number: 019348925092; Model Number: DYNJ66356, UPC Number: 019348934445; Model Number: DYNJ66356A, UPC Number: 019348983939; Model Number: DYNJ66356B, UPC Number: 019348994135; Model Number: DYNJ66356C, UPC Number: 019348999105; Model Number: DYNJ66356D, UPC Number: 019532706029; Model Number: DYNJ66577, UPC Number: 019348936096; Model Number: DYNJ68492A, UPC Number: 019348991395; Model Number: DYNJ68492B, UPC Number: 019532703330; Model Number: DYNJ68492C, UPC Number: 019532720566; Model Number: DYNJ68492D, UPC Number: 019532734221; Model Number: DYNJ68863, UPC Number: 019348984540; Model Number: DYNJ68863A, UPC Number: 019532702645; Model Number: DYNJ68880, UPC Number: 019348984772; Model Number: DYNJ80599, UPC Number: 019532705334; Model Number: DYNJ81626, UPC Number: 019532712706; Model Number: DYNJ82016, UPC Number: 019532716359; Model Number: DYNJ82104, UPC Number: 019532717108; Model Number: DYNJ82144, UPC Number: 019532717803; Model Number: DYNJ82769, UPC Number: 019532720722; Model Number: DYNJ82769A, UPC Number: 019532735023; Model Number: DYNJ83146, UPC Number: 019532723568. b. Model Number: DYNJ59778A, UPC Number: 019348959858; Model Number: DYNJ59778B, UPC Number: 019348969592. c. Model Number: DYNJ59245, UPC Number: 088827776727; Model Number: DYNJ59245A, UPC Number: 019532703914. d. Model Number: DYNJ39866B, UPC Number: 088994270504; Model Number: DYNJ39866C, UPC Number: 019532717634. e. Model Number: DYNJ68404, UPC Number: 019348983069. f. Model Number: DYNJ0250564O, UPC Number: 019348956435; Model Number: DYNJ0250564P, UPC Number: 019532708884; Model Number: DYNJ0373040N, UPC Number: 019348987387; Model Number: DYNJ0493141G, UPC Number: 019348956435; Model Number: DYNJ0493141I, UPC Number: 019348956435; Model Number: DYNJ0493141J, UPC Number: 019348992622; Model Number: DYNJ0871182AC, UPC Number: 019532733085; Model Number: DYNJ0901358I, UPC Number: 019348956435; Model Number: DYNJ0901358J, UPC Number: 019348956435; Model Number: DYNJ0901358K, UPC Number: 019532734322; Model Number: DYNJ53475F, UPC Number: 019348942486; Model Number: DYNJ53684A, UPC Number: 019348938687; Model Number: PHS400047N, UPC Number: 019348996690; Model Number: PHS400047O, UPC Number: 019532712350. g. Model Number: DYNJ906440A, UPC Number: 019348931287. h. Model Number: DYNJ56858, UPC Number: 088994268907. i. Model Number: DYNJ905079F, UPC Number: 019532720900. j. Model Number: DYNJ900714B, UPC Number: 019348922643; Model Number: DYNJ900714C, UPC Number: 019348995136. k. Model Number: DYNJ52586B, UPC Number: 019532721211. l. Model Number: DYNJ52586, UPC Number: 088994229774; Model Number: DYNJ52586A, UPC Number: 019348949439; Model Number: DYNJ52586B, UPC Number: 019532721211. m. Model Number: DYNJ69272A, UPC Number: 019532701580. n. Model Number: DYNJ62889, UPC Number: 019348969667. o. Model Number: DYNJ64396, UPC Number: 019348981050. p. Model Number: DYNJ49874, UPC Number: 088827789060. q. Model Number: DYNJ52123, UPC Number: 088994224214. r. Model Number: DYNJ68667, UPC Number: 019348983731. s. Model Number: DYNJ35586G, UPC Number: 019348966323; Model Number: DYNJ39408F, UPC Number: 019348969283; Model Number: DYNJ65189B, UPC Number: 019348943314. t. Model Number: DYNJ44737B, UPC Number: 019348935171. u. Model Number: DYNJ57047, UPC Number: 088994271048. v. Model Number: DYNJ64190, UPC Number: 019348979335. w. Model Number: DYNJ65560A, UPC Number: 019348939718. x. Model Number: DYNJ21949J, UPC Number: 088994212841; Model Number: DYNJ39005B, UPC Number: 019348956435; Model Number: DYNJ39889, UPC Number: 088438979693; Model Number: DYNJ48493, UPC Number: 088827759997; Model Number: DYNJ48907F, UPC Number: 088994252942; Model Number: DYNJ50785, UPC Number: 088994210530; Model Number: DYNJ52098, UPC Number: 088994223706; Model Number: DYNJ52993A, UPC Number: 019348936103; Model Number: DYNJ53160, UPC Number: 088994238558; Model Number: DYNJ53160A, UPC Number: 019348974565; Model Number: DYNJ54153B, UPC Number: 088994271442; Model Number: DYNJ55268, UPC Number: 088994253967; Model Number: DYNJ55462A, UPC Number: 019348928316; Model Number: DYNJ55514A, UPC Number: 088994272740; Model Number: DYNJ55849A, UPC Number: 088994268001; Model Number: DYNJ56624, UPC Number: 088994266543; Model Number: DYNJ56724A, UPC Number: 088994282388; Model Number: DYNJ56724B, UPC Number: 019348946631; Model Number: DYNJ57512, UPC Number: 088994274827; Model Number: DYNJ57835, UPC Number: 088994278233; Model Number: DYNJ57917, UPC Number: 088994279429; Model Number: DYNJ58063, UPC Number: 088994281667; Model Number: DYNJ58609, UPC Number: 088994287126; Model Number: DYNJ59151F, UPC Number: 019348948756; Model Number: DYNJ59662B, UPC Number: 019348943433; Model Number: DYNJ59662D, UPC Number: 019532703087; Model Number: DYNJ59677A, UPC Number: 019348961635; Model Number: DYNJ59681A, UPC Number: 019348946987; Model Number: DYNJ61540C, UPC Number: 019348949512; Model Number: DYNJ63823, UPC Number: 019348976342; Model Number: DYNJ64282, UPC Number: 019348979637; Model Number: DYNJ64471A, UPC Number: 019348941415; Model Number: DYNJ65579, UPC Number: 019348928038; Model Number: DYNJ66154, UPC Number: 019348931778; Model Number: DYNJ66743A, UPC Number: 019348943555; Model Number: DYNJ68749, UPC Number: 019348983668; Model Number: DYNJ69091, UPC Number: 019348988372; Model Number: DYNJ80199A, UPC Number: 019532704086; Model Number: DYNJ80199B, UPC Number: 019532708820; Model Number: DYNJ80868, UPC Number: 019532708250; Model Number: DYNJ83147, UPC Number: 019532723550. y. Model Number: DYNJ66427, UPC Number: 019348935468. z. Model Number: DYNJ66271A, UPC Number: 019348981468; Model Number: DYNJ66271C, UPC Number: 019532709850. aa. Model Number: DYNJ65342A, UPC Number: 019348936966. bb. Model Number: DYNJ38264D, UPC Number: 019348943849; Model Number: DYNJ62038A, UPC Number: 019348932240; Model Number: DYNJ64909, UPC Number: 019348923016. cc. Model Number: DYNJ53616A, UPC Number: 088994268856. dd. Model Number: DYNJ57003, UPC Number: 088994270310; Model Number: DYNJ62829A, UPC Number: 019348930662. ee. Model Number: DYNJ50227C, UPC Number: 088994293861. ff. Model Number: DYNJ61010A, UPC Number: 019348930714. gg. Model Number: DYNJ44421D, UPC Number: 019348948263. hh. Model Number: DYNJ83461, UPC Number: 019532726779. ii. Model Number: CDS984292I, UPC Number: 019348986248. jj. Model Number: DYNJ66076, UPC Number: 019348931923. kk. Model Number: DYNJ66445, UPC Number: 019348935608. ll. Model Number: DYNJ33612G, UPC Number: 019532720495.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2290-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2291-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2292-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2293-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2294-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2295-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2296-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2297-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2298-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2299-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2300-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2301-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2302-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2303-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2304-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2305-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2306-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2307-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2308-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2309-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2310-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2311-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2312-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2313-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2314-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2315-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2316-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2317-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2318-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2319-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2320-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2321-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2322-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2323-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2324-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2325-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2326-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2327-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2328-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2329-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2330-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2331-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2332-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2333-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2334-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2335-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2336-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2337-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2338-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2339-2023 | 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.