B. Braun Recalls Safeline Y-Type Blood Sets Due to Leakage Risk
B. Braun Medical is recalling 3,300 units of Safeline Y-Type Blood Sets due to a potential for leakage at the joint between the blood filters and tubing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 3,300 units of Safeline Y-Type Blood Sets, Catalog Number NF5140. The recall is due to a potential for leakage at the joint between the blood filters and tubing.
The affected products are distributed nationwide in the United States. The recall includes units with Lot Numbers 61681745 (Expiration Date: May 31, 2024) and 61685109 (Expiration Date: June 30, 2024). The GUIDID for the affected units is 04046964187483.
Healthcare facilities and consumers should stop using the affected blood sets and contact B. Braun Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- Safeline Y-Type Blood Set, Catalog Number NF5140
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 3,300
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 (3)
- GUIDID: 04046964187483 Lot Numbers: 61681745 - Expiration Date: May 31
- 2024
- 61685109 - 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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