B. Braun Gravity Mixing Container Recalled for Temperature Exposure
B. Braun EVA Gravity Mixing Container 1000 mL units may have been exposed to higher temperatures during storage prior to delivery, potentially affecting product effectiveness. Units distributed nationwide between June and September 2021 are affected.
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: This is an FDA Class II medical device recall where temperature exposure may have impacted product effectiveness. The source reports no illnesses or injuries, and the hazard is theoretical rather than documented. Per the rubric, recalls with no reported illnesses and theoretical hazards score at most 3 (High); the medical device category and potential effectiveness issue justify this score over a lower rating.
Plain-English summary
B. Braun EVA Gravity Mixing Container 1000 mL (Model 2112363) has been recalled due to exposure to higher temperatures prior to delivery that may have impacted product effectiveness. Temperature excursions occurred between June and August 2021.
All units received between June 1, 2021, and September 30, 2021, are affected by this recall. The products were distributed nationwide and are manufactured by Mckesson Medical-Surgical Inc.
Consumers or healthcare facilities with affected units should contact the manufacturer for guidance on verification or replacement.
The recalled product
- Product
- B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-exposure
- product-effectiveness
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)
- GTIN: 04046964244926
- 04046964244940
- 04046964244933
Distribution
Distributed nationwide across the United States.
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