—#203427

Product

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

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K952516
Affected lot / code info: UDI/DI 30351688028635, Lot Number 4331283

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: US

Timeline

Recall initiated: 2023-09-06
Posted by FDA: 2023-10-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203427. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.