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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

B. Braun Medical, Inc.: Potential for leakage at the joint between the blood filters and tubing

Agency Publication Date: February 2, 2020
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Affected Products

Product: Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005

GUIDID: 04046955202799 Lot Numbers: 61679395 - Expiration Date: May 31, 2022, 61685454 - Expiration Date: June 30, 2022

Lot Numbers:
Numbers
Product: Y-Type Blood Set, Catalog Number 490293

GUIDID: 04046964539657 Lot Number: 61681734 Expiration Date: May 31, 2022

Lot Numbers:
Number
Product: Y-Type Blood Set, Catalog Number 490314

GUIDID: 04046964527180 Lot Numbers: 61674868 - Expiration Date April 30, 2022, 61677175 - Expiration Date April 30, 2022, 61678259 - Expiration Date May 31, 2022, 61685087 - Expiration Date June 30, 2022

Lot Numbers:
Numbers
Product: Y-Type Blood Set, Catalog Number 490425

GUIDID: 04046964813702 Lot Numbers: 61674871 - Expiration Date: April 30, 2022, 61680607 - Expiration Date: May 31, 2022, 61685094 - Expiration Date: June 30, 2022

Lot Numbers:
Numbers
Product: Y-Type Blood Set, Catalog Number 490530

GUIDID: 04046955203321 Lot Numbers: 61674878 - Expiration Date: April 30, 2022, 61677192 - Expiration Date: April 30, 2022, 61678186 - Expiration Date: April 30, 2022, 61681736 - Expiration Date: May 31, 2022, 61685105 - Expiration Date: June 30, 2022

Lot Numbers:
Numbers
Product: Safeline Y-Type Blood Set, Catalog Number NF5140

GUIDID: 04046964187483 Lot Numbers: 61681745 - Expiration Date: May 31, 2024, 61685109 - Expiration Date: June 30, 2024

Lot Numbers:
Numbers
Product: Safeline Y-Type Blood Set, Catalog Number V2500

GUIDID: 04046964188633 Lot Numbers: 61674884 - Expiration Date: April 30, 2024, 61677634 - Expiration Date: April 30, 2024, 61678262 - Expiration Date: May 31, 2024, 61680625 - Expiration Date: May 31, 2024, 61685110 - Expiration Date: June 30, 2024

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84365
Status: Resolved
Manufacturer: B. Braun Medical, Inc.
Manufactured In: United States
Units Affected: 7 products (1,824 units; 1,050 units; 5,616 units; 2,736 units; 9,000 units; 3,300 units; 19,500 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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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.