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Open, Classified

Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

FDA Recall Z-0141-2024 · Posted 2023-10-20

Recalling FirmSmiths Medical ASD Inc.
Recall StatusOpen, Classified
Product CodeJKA
Date Initiated2023-09-06
Product Quantity31900 devices

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.

Firm Action

Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 09/06/2023 by mail. The notice explained the problem with the device, potential risk, and requested the following: 1. Discontinue use, distribution, and quarantine all affected product in inventory. 2. Notify all potential users within the consignee organization 3. Distributors were directed to notify their customers. Questions: Customer Service 1-(800)-258-5361

Root Cause

Process control

Distribution Pattern

US

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K952516PRO-VENT, LINE DRAW, PULSATORSmiths Industries Medical Systems, Inc. · 1995-07-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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