Z-1795-2020 Class II Terminated
FDA device recall Z-1795-2020 was initiated by Becton Dickinson & Company on March 26, 2020 and is designated Class II. Reason for recall: The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle. The recall status is terminated (terminated August 21, 2020). Affected quantity: 900.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- March 26, 2020
- Termination Date
- August 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 900
Product Description
CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986
Reason for Recall
The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle.
Distribution Pattern
Domestic distribution to the following states: Alabama, Colorado, Illinois, Massachusetts, Missouri, Oklahoma, Rhode Island, Virginia, and Wisconsin.
Code Information
Lot Number: 0001304986