Z-0141-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2023
- Initiation Date
- September 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31900 devices
Product Description
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Reason for Recall
The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under the FGSKU# 4599P-1 and Lot# 4331283. Tubes without caps have the potential to generate delayed or erroneous test results and/or exposure to infectious blood.
Distribution Pattern
US
Code Information
UDI/DI 30351688028635, Lot Number 4331283