Z-0953-2021 Class II Terminated
FDA device recall Z-0953-2021 was initiated by Ethicon, Inc. on January 4, 2021 and is designated Class II. Reason for recall: Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach The recall status is terminated (terminated November 29, 2023). Affected quantity: 23,580 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- February 10, 2021
- Initiation Date
- January 4, 2021
- Termination Date
- November 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,580 eaches
Product Description
Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12
Reason for Recall
Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach
Distribution Pattern
US Nationwide
Code Information
Lot Number: QEBBTQ Exp. Date: April 30, 2022 GTIN: 10705031203532