B. Braun Recalls 26-Lead Transfer Sets for Valve Orientation Defect
B. Braun Medical is recalling 26-Lead Transfer Sets for the APEX Compounding System because valves may be incorrectly oriented, posing a risk of unintended admixture.
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 unintended admixture in a medical device, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling 26-Lead Transfer Sets used with the APEX Compounding System. The recall involves 12,320 units of the product, identified by Product Catalog Number 2112550. The affected products were distributed to healthcare facilities in 21 US states, including Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, Ohio, Pennsylvania, Texas, and Washington.
The recall was initiated because there is a potential for the valves on the transfer sets to be incorrectly oriented. If a transfer set with an incorrectly oriented valve is installed on the system, there is a potential for unintended admixture of the compounded medications.
Healthcare facilities and consumers should check their inventory for the specific product catalog number and lot codes listed in the official recall notice. If the product is found, it should be removed from use and returned to B. Braun Medical, Inc. according to the instructions provided by the manufacturer.
The recalled product
- Product
- 26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 12,320
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 (20)
- 0061546906
- 0061546910
- 0061548145
- 0061548146
- 0061548476
- 0061548477
- 0061548478
- 0061548479
- 0061548645
- 0061555100
- 0061555101
- 0061555102
- 0061556350
- 0061557521
- 0061559077
- 0061559628
- 0061559631
- 0061559852
- 0061559853
- 0061559854
Distribution
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