Trinity Sterile, Inc. Recall 90625
Description: Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
Trinity Sterile, Inc. Recall 90625 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1551-2022 |
| Event ID | 90625 |
| Event Description | Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of FL, PA. |
| Quantity | 4,169 cases (125,070 eaches) |
| Recall 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 |
| Device Classification | 20220824 |
| Device Code Info | UDI-DI: 10850007185722 Case 00850007185725 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600008 600009 600010 600011 600012 600013 600014 600015 600017 600018 600019 |
| Center Classification Date | 20220818 |
| Recall Initiation Date | 20220629 |
| Recalling Firm | Trinity Sterile, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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