Z-1550-2022 Class II Terminated
FDA device recall Z-1550-2022 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: 2,512 cases (75,360 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
- 2,512 cases (75,360 eaches )
Product Description
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
Distribution Pattern
US Nationwide distribution in the states of FL, PA.
Code Information
UDI-DI: 10850007185746 Case 00850007185749 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600008 600009 600010 600011 600012