The Recall Desk
HighFDA (Devices)·Z-2343-2018·Announced 2018-07-11

B. Braun Recalls 26-Lead Transfer Sets for Valve Orientation Defect

B. Braun Medical is recalling 26-Lead Transfer Sets for the APEX Compounding System because valves may be incorrectly oriented, posing a risk of unintended admixture.

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 hazard involves a risk of unintended admixture in a medical device, which fits the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

B. Braun Medical, Inc. is recalling 26-Lead Transfer Sets used with the APEX Compounding System. The recall involves 12,320 units of the product, identified by Product Catalog Number 2112550. The affected products were distributed to healthcare facilities in 21 US states, including Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, Ohio, Pennsylvania, Texas, and Washington.

The recall was initiated because there is a potential for the valves on the transfer sets to be incorrectly oriented. If a transfer set with an incorrectly oriented valve is installed on the system, there is a potential for unintended admixture of the compounded medications.

Healthcare facilities and consumers should check their inventory for the specific product catalog number and lot codes listed in the official recall notice. If the product is found, it should be removed from use and returned to B. Braun Medical, Inc. according to the instructions provided by the manufacturer.

The recalled product

Product
26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Pharmaceutical Compounding
Hazard
Affected units
12,320

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 (20)

  • 0061546906
  • 0061546910
  • 0061548145
  • 0061548146
  • 0061548476
  • 0061548477
  • 0061548478
  • 0061548479
  • 0061548645
  • 0061555100
  • 0061555101
  • 0061555102
  • 0061556350
  • 0061557521
  • 0061559077
  • 0061559628
  • 0061559631
  • 0061559852
  • 0061559853
  • 0061559854

Distribution

Distributed in 20 states:

Related recalls

Same manufacturer · B. Braun Medical, Inc.

See all →