Z-1269-2020 Class II Terminated
FDA device recall Z-1269-2020 was initiated by TELEFLEX MEDICAL INC on January 13, 2020 and is designated Class II. Reason for recall: There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed. The recall status is terminated (terminated November 24, 2021). Affected quantity: 1764 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- January 13, 2020
- Termination Date
- November 24, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1764 units
Product Description
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
Reason for Recall
There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
Distribution Pattern
Worldwide
Code Information
Lot Number 74B1500674