B. Braun Medical Recalls Accu-Bloc Perifix Kits Due to Filter Damage
B. Braun Medical is recalling 200 units of Accu-Bloc Perifix Kits because damaged filter membranes may prevent the device from achieving required 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, and the defect involves a functional failure of a medical device component (filter membrane) that poses a risk of harm, fitting the 'High' severity criteria for risk-of-harm products where specific injury reports are not detailed in the source text.
Plain-English summary
B. Braun Medical, Inc. is recalling 200 units of the CE18HKN ACCU-BLOC PERIFIX KIT NRFIT (Catalog # 339189). The recall is due to damage of the filter membrane, which prevents the device from achieving its required filter capacity.
The affected units are identified by Lot # 0061620283 and UDI 04046964943294. These products were distributed to facilities in California, Florida, Missouri, Texas, Minnesota, Alabama, Georgia, North Carolina, Illinois, and Pennsylvania.
This is an FDA Class II recall. Healthcare providers and patients should stop using the affected kits and contact B. Braun Medical for further instructions.
The recalled product
- Product
- CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 200
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 (1)
- Lot # 0061620283 UDI: 04046964943294
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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