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Lower risk Medical device recall · FDA · Published November 20, 2019

B. Braun Y-Type Blood Set Recall: Leakage Risk at Filters

B. Braun recalls Y-Type Blood Set (Catalog 490425) due to potential leakage at blood filters and tubing joints. Affected units have specific lot numbers and expiration dates.

🇺🇸 FDA recall #Z-0938-2020Medical deviceB. Braun ›
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Contact the company

Recalling firmB. Braun Medical, Inc.901 Marcon Blvd · Allentown, PA 18109-9512
✎ GovInfoNow plain-language explainer

B. Braun is recalling Y-Type Blood Sets with catalog number 490425 because they may leak at the joint between blood filters and tubing. This could lead to blood loss or contamination during medical procedures. Read more at govinfonow.com/recall/66469-b-braun-y-type-blood-set-recall-leakage-risk-at.

Source Summary by GovInfoNow · govinfonow.com/recall/66469-b-braun-y-type-blood-set-recall-leakage-risk-at · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0938-2020

Cite this page

“B. Braun Y-Type Blood Set Recall: Leakage Risk at Filters.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66469-b-braun-y-type-blood-set-recall-leakage-risk-at. Based on FDA recall #Z-0938-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0938-2020%22&limit=1).

B. Braun Medical, Inc. recalled Y-Type Blood Sets with catalog number 490425 due to potential leakage at the joint between blood filters and tubing, the FDA said on Nov. 20, 2019. Owners should contact the company for a refund.

How to tell if you have it

  • Brand: B. Braun
  • Product: Y-Type Blood Set
  • Catalog Number: 490425
  • Lot Numbers: 61674871 (Expiration Date: April 30, 2022), 61680607 (Expiration Date: May 31, 2022), 61685094 (Expiration Date: June 30, 2022)
  • Units affected: 2,736

The hazard

The recall cites the potential for leakage at the joint between the blood filters and tubing.

Context

GovInfoNow's records show B BRAUN MEDICAL INC has 66 other recalls on record since Oct. 15, 2013. Other recent recalls of similar products include B. Braun Medical 100mL Sodium Chloride Injection Recall (Aug. 19, 2026), B. Braun Medical Lactated Ringer's Injection Recall (Aug. 12, 2026), and B Braun Discofix Four Way Stopcock Recall (Aug. 4, 2026). Other recent recalls of similar products include Fresenius Medical Care 5008X Blood Tubing Set Recall (Aug. 10, 2026), Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall (Aug. 10, 2026), and ICU Medical Pulsator Arterial Blood Sampling Kit Recall (Dec. 19, 2025).

How to tell if you have this one

Check for the catalog number 490425 on the product. Affected units have lot numbers 61674871 (expiring April 30, 2022), 61680607 (expiring May 31, 2022), or 61685094 (expiring June 30, 2022).

  • Brand
    B. Braun
  • Category
    Medical device
FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US Nationwide
Recall numberProduct, codes & lotsQuantity
Z-0935-2020Outlook 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, 20221,824 units
Z-0936-2020Y-Type Blood Set, Catalog Number 490293; GUIDID: 04046964539657 Lot Number: 61681734 Expiration Date: May 31, 20221,050 units
Z-0937-2020Y-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, 20225,616 units
Z-0938-2020Y-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, 20222,736 units
Z-0939-2020Y-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, 20229,000 units
Z-0940-2020Safeline Y-Type Blood Set, Catalog Number NF5140; GUIDID: 04046964187483 Lot Numbers: 61681745 - Expiration Date: May 31, 2024, 61685109 - Expiration Date: June 30, 20243,300 units
Z-0941-2020Safeline 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, 202419,500 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the catalog number 490425 and affected lot numbers on the product packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Nov 20, 201912. FDA classified it Class II: Feb 1, 202023. Published in FDA’s Enforcement Report: Feb 12, 202034. FDA terminated the recall: Oct 16, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0938-2020 (November 20, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0938-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA