B. Braun Outlook Safety Infusion System Y-type Blood Set Recall for Leakage
B. Braun Medical is recalling 1,824 Outlook Safety Infusion System Y-type Blood Sets due to 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 potential for leakage in a medical device where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
B. Braun Medical, Inc. is recalling 1,824 units of the Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005. 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 specific lot numbers involved are 61679395 (expiration date May 31, 2022) and 61685454 (expiration date June 30, 2022). The GUIDID for the product is 04046955202799.
Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected blood sets. B. Braun Medical is the recalling firm responsible for this action.
The recalled product
- Product
- Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Infusion System
- Hazard
- Affected units
- 1,824
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: 04046955202799 Lot Numbers: 61679395 - Expiration Date: May 31
- 2022
- 61685454 - 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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