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 | Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility |
| Product | Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l |
| Quantity | 2970 units |
| Distribution | US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA. |
| Initiated | 2021-02-23 |
| Classified | 2021-04-21 |
| Terminated | 2023-02-16 |
| Recall number | Z-1468-2021 |
| 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-1468-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87538/
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