Z-0846-2019 Class II Terminated
FDA device recall Z-0846-2019 was initiated by Teleflex Medical on January 7, 2019 and is designated Class II. Reason for recall: The internal tip is missing from the device, causing the device to not function as intended. The recall status is terminated (terminated November 4, 2021). Affected quantity: 80 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 27, 2019
- Initiation Date
- January 7, 2019
- Termination Date
- November 4, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 units
Product Description
Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
Reason for Recall
The internal tip is missing from the device, causing the device to not function as intended.
Distribution Pattern
TX, NY, DC and Philippines
Code Information
Lot/Batch Numbers: A8, C8, I7