Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF — Class II medical device recall Z-1550-2022
Terminated recall by Trinity Sterile, Inc., reported 2022-08-24, distributed nationwide. Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubb
| Recall number | Z-1550-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trinity Sterile, Inc., Salisbury, MD, United States |
| Recall initiated | 2022-06-29 |
| Classified | 2022-08-18 |
| Reported by FDA | 2022-08-24 |
| Terminated | 2024-05-10 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00850007185749, 10850007185746 |
| Lot numbers | 600000, 600001, 600002, 600003, 600004, 600005, 600008, 600009, 600010, 600011, 600012 |
| Model numbers | DC5040LF |
Product
Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1550-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.