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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Smiths Medical ASD, Inc.: Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.; Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

Agency Publication Date: April 15, 2020
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Affected Products

Product: Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes

Portex Pro-Vent Arterial Blood Sampling Kit: Item Number Lot Number G1724 3859779 G1702 3863522 4599P-1 3859751 4599P-1 3862142 4599P-1 3863544 4599P-1 3863545 4599P-1 3869581 G1665 3856947 4588P-2 3862145 4558PE 3859727

Lot Numbers:
Number
Product: Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes

Portex LineDraw Arterial Blood Sampling Syringe: Item Number Lot Number 4042-2 3848838 4042-2 3848878 4042-2 3856950 4042-2 3859774 4042LH 3856958 4042LH 3859747

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84681
Status: Resolved
Manufacturer: Smiths Medical ASD, Inc.
Manufactured In: United States
Units Affected: 2 products (720,100 total devices; 127,700 total devices)
Agency Last Updated: June 25, 2020

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.