FDA Device recall Z-2228-2024
Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curv…
- FDA Device
- Class II
- ongoing
- Published 2024-07-10
On 2024-07-10 the FDA classified a Class II recall of Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curv… by Medline Industries Northfield, citing surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2228-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-14 |
| Published | 2024-07-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. b. Medline Cath Lab Pack, Pack #DYNJ56141A, containing a Pure Pouch containing component Medline DYND0400 O.R. Scissors, S/B, 5.5 Sterile. c. Medline Sterile Loop Insertion Tray, Pack DYNJ62843A, containing a Pure Pouch containing Medline Reorder #DYNJ04048, Kelly Forceps/Std Str Sterile. d. Medline Radiology Minor MVH, Pack #DYNJ63555C, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. e. Medline Basic Pack, Pack #DYNJ80649B, containing a Pure Pouch containing component Medline DYND0400 O.R. Scissors, S/B, 5.5 Sterile.
Reason
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Identifiers
| code_info | a. Pack #DYNJ47873K - lot numbers 23HBK868, exp. 8/31/2027, 23HBC082exp. 2/29/2028, 23GBC462, exp. 1/31/2028, and 23D…a. Pack #DYNJ47873K - lot numbers 23HBK868, exp. 8/31/2027, 23HBC082exp. 2/29/2028, 23GBC462, exp. 1/31/2028, and 23DBK792, exp. 11/30/2027, UDI-DI each 10193489466812 and UDI-DI case-40193489466813. b. Pack #DYNJ56141A - lot numbers 23IBK595, exp. 1/31/2025, UDI-DI each-10193489555585 and UDI-DI case-40193489555586. c. Pack DYNJ62843A - lot numbers 24ABP043, exp. 12/31/2024, and 23IBM893, exp. 3/31/2025, UDI-DI each-10195327001766 and UDI-DI case-40195327001224. d. Pack #DYNJ63555C - lot numbers 24ALA613, exp. 3/31/2025; 23KLA748, 1/31/2025; 23KLA017, exp. 1/31/2025; 23JLA853, exp. 1/31/2025; 23JLA232. exp. 1/31/2025; 23ILB006, exp. 1/31/2025; 23ILA201, exp. 12/31/2024; and 23HLA429, exp. 12/31/2024; UDI-DI each-10193489816525 and UDI-DI case-40193489816526. e. Pack #DYNJ80649B - lot number 23JBG046, exp. 5/31/2026, UDI-DI each-10195327269944 and UDI-DI case-40195327269945. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2228-2024%22
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