Z-1548-2022 Class II Terminated
FDA device recall Z-1548-2022 was initiated by Trinity Sterile, Inc. on June 29, 2022 and is designated Class II. 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 The recall status is terminated (terminated May 10, 2024). Affected quantity: 5 cases (125 eaches ).
Recall Details
- Product Type
- Devices
- Report Date
- August 24, 2022
- Initiation Date
- June 29, 2022
- Termination Date
- May 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 cases (125 eaches )
Product Description
Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
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
Distribution Pattern
US Nationwide distribution in the states of FL, PA.
Code Information
UDI-DI Number: 50649111317590 Case 10649111317590 Kit Lot Numbers: 600001 600002