Recall record at a glance
| Official record | Z-2303-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Report date | Aug 9, 2023 |
| Recall initiation date | May 15, 2023 |
| Quantity | 100,549 kits |
| Location | Northfield, IL, United States |
Official product description
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
Why the product was recalled
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Distribution information
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
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