Class II — Trinity Sterile, Inc.
| Recalling firm | TRINITY STERILE, INC. |
|---|---|
| Registered facility | TRINITY STERILE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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 |
| Product | Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF |
| Quantity | 2,512 cases (75,360 eaches ) |
| Distribution | US Nationwide distribution in the states of FL, PA. |
| Initiated | 2022-06-29 |
| Classified | 2022-08-18 |
| Terminated | 2024-05-10 |
| Recall number | Z-1550-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Trinity Sterile, Inc. (Z-1550-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90625/
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