FDA Device recall Z-2229-2024
Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scisso…
- FDA Device
- Class II
- ongoing
- Published 2024-07-10
On 2024-07-10 the FDA classified a Class II recall of Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scisso… 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-2229-2024 |
| 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
Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile. b. Medline C-Section, Pack DYNJ902938J, containing a Pure Pouch with component Reorder #DYND04000, 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 #DYNJ901130I - Lot numbers 23GMH075, exp. 7/31/2024, and 23GMD605, exp. 7/31/2024, UDI-DI each-10193489946055…a. Pack #DYNJ901130I - Lot numbers 23GMH075, exp. 7/31/2024, and 23GMD605, exp. 7/31/2024, UDI-DI each-10193489946055 and UDI-DI case-40193489946056. b. Pack DYNJ902938J - Lot numbers 23LMD530, 23IMG375, 23HMB336, 23GMF342, 23EMJ935, and 23EMK254, all exp. date 8/31/2024, UDI-DI each-10193489946116, UDI-DI case 40193489946117. |
|---|
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-2229-2024%22
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