FDAClass IINovember 1, 2023

Portex Pro-Vent Arterial Blood Sampling Kit with Dry recall

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

Why was Portex Pro-Vent Arterial Blood Sampling Kit with Dry 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 30351688028635, Lot Number 4331283

Product
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Recalling firm
Smiths Medical ASD Inc.
Quantity
31900 devices
Distribution
US
Recall date
November 1, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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