Recall Z-0141-2024— Smiths Medical ASD Inc.

Name: FDA recall Z-0141-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-06

Class II · Ongoing

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2023-09-06. It names one FDA 510(k) clearance: K952516. Product: 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..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-09-06
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K952516 — PRO-VENT, LINE DRAW, PULSATORSmiths Industries Medical Systems, Inc.·cleared 1995-07-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.