Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0141-2024.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0141-2024.
Recall ongoing. Follow firm instructions.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0141-2024.
Smiths Medical ASD Inc.
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Smiths Medical Asd Inc. Recall FAQ
Smiths Medical Asd Inc. is the subject of a medical devices safety report: Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1. The notice was published on September 6, 2023 by the U.S. Food and Drug Administration (FDA). Approximately 31,900 units are potentially affected.