B. Braun Anesthesia Support Tray Temperature Excursion Recall
B. Braun Medical Inc. is recalling Anesthesia Support Trays distributed between June and September 2021 due to temperature excursions during storage that may have affected product effectiveness.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—temperature exposure 'may have impacted' product effectiveness—making this a precautionary recall based on storage conditions rather than confirmed product failure or patient harm.
Plain-English summary
B. Braun Medical Inc., through distributor Mckesson Medical-Surgical Inc., is recalling Anesthesia Support Tray model 332116 (Support Tray with Extended Set, 10 cases per package) distributed nationwide.
From June through August 2021, affected units were exposed to temperature excursions at the manufacturing facility prior to delivery. Exposure to higher temperatures may have compromised the product's effectiveness.
The recall applies to all cases received between June 1, 2021 and September 30, 2021, identified by GTIN 04046964177538 and 04046964177545. A total of 16 cases were distributed.
The FDA has not reported any injuries or illnesses associated with this product. Healthcare facilities and providers should verify whether they received affected lots. Contact Mckesson Medical-Surgical Inc. for instructions on returning or replacing units.
The recalled product
- Product
- B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY, +EXT SET(10/CS)ST200E Model Number: 332116
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-excursion
- product-effectiveness-degradation
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 (2)
- GTIN: 04046964177538
- 04046964177545
Distribution
Distributed nationwide across the United States.
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