B. Braun Medical Recalls Accu-Bloc Perifix Kits Due to Filter Damage
B. Braun Medical is recalling 3,820 units of Accu-Bloc Perifix Kits because damage to the filter membrane prevents the device from achieving its intended filter capacity.
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. The hazard involves a medical device failing to achieve its intended filter capacity, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
B. Braun Medical, Inc. is recalling 3,820 units of the CE18TKN ACCU-BLOC PERIFIX KIT NRFIT (Catalog # 339188). The recall is due to damage of the filter membrane, which results in the filter capacity not being achieved.
The affected lots are 0061537846 (expiration 8/31/2018), 0061537847 (expiration 10/31/2018), and 0061620282 (expiration 9/30/2019). The product was distributed in California, Florida, Missouri, Texas, Minnesota, Alabama, Georgia, North Carolina, Illinois, and Pennsylvania.
The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected kits and contact B. Braun Medical for further instructions.
The recalled product
- Product
- CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 3,820
Distribution
Part of a larger recall action
This product is one of 9 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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