FDA Enforcement
Class II
Ongoing
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Recall: Z-0141-2024
·
Reported November 1, 2023
Enforcement
- Recall Number
- Z-0141-2024
- Event ID
- 93094
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Smiths Medical ASD Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 1, 2023
- Initiation Date
- September 6, 2023
- Classification Date
- October 20, 2023
- Address
- 6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States
Description
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Reason
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.
Code Info
UDI/DI 30351688028635, Lot Number 4331283
Distribution
US
Quantity
31900 devices