Agency classClass IIOur severity:High FDA (Devices)·Z-2473-2019·Announced 2019-09-11

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.

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 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
Hazard: filter-failure
device-defect
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

Distributed in 10 states:

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.

See all 9 products in this recall →

Same manufacturer · B. Braun Medical, Inc.

See all →

Critical
B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-16
Low
B Braun Recalls Discofix Stopcock Sets Due to Incorrect Expiration Date
FDA (Devices) · 2026-09-09
Severe
B. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
Moderate
B. Braun UPMC double catheter trays contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
Moderate
B. Braun spinal epidural kits contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10

Same hazard · filter failure