B. Braun Recalls Y-Type Blood Sets Due to Leakage Risk
B. Braun Medical is recalling 9,000 Y-Type Blood Sets because of a potential for leakage at the joint between the blood filters and tubing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (leakage) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
B. Braun Medical, Inc. is recalling 9,000 units of Y-Type Blood Sets, Catalog Number 490530. The recall is due to a potential for leakage at the joint between the blood filters and tubing.
The affected products were distributed nationwide in the United States. The recall includes specific lot numbers with expiration dates ranging from April 30, 2022, to June 30, 2022.
Healthcare facilities and consumers should stop using the affected blood sets and contact B. Braun Medical for further instructions or a replacement.
The recalled product
- Product
- Y-Type Blood Set, Catalog Number 490530
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 9,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- GUIDID: 04046955203321 Lot Numbers: 61674878 - Expiration Date: April 30
- 2022
- 61677192 - Expiration Date: April 30
- 61678186 - Expiration Date: April 30
- 61681736 - Expiration Date: May 31
- 61685105 - Expiration Date: June 30
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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