FDA Device recall Z-1550-2022
Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
- FDA Device
- Class II
- terminated
- Published 2022-08-24
On 2022-08-24 the FDA classified a Class II recall of Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF by Trinity Sterile, citing kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1550-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-29 |
| Published | 2022-08-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Trinity Sterile |
| Distribution | US |
Product
Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
Reason
Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
Identifiers
| code_info | UDI-DI: 10850007185746 Case 00850007185749 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600008 600009 600010 600011 600012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1550-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.