FDA Device recall Z-2343-2018

26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550

FDA Device
Class II
terminated
Published 2018-07-11

On 2018-07-11 the FDA classified a Class II recall of 26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550 by B Braun Medical, citing there is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there is….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2343-2018
Classification	Class II
Status	terminated
Initiated	2018-06-04
Published	2018-07-11
Last updated	2026-09-13 11:54 UTC
Company	B Braun Medical
Distribution	AL, CA, CO, CT, FL, GA, IL, LA, MA, MD, MI, MN, MO, NC, NJ, NV, OH, PA, TX, WA

Product

26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550

Reason

There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there is potential for unintended admixture.

Identifiers

code_info	0061546906, 0061546910, 0061548145, 0061548146, 0061548476, 0061548477, 0061548478, 0061548479, 0061548… 0061546906, 0061546910, 0061548145, 0061548146, 0061548476, 0061548477, 0061548478, 0061548479, 0061548645, 0061555100, 0061555101, 0061555102, 0061556350, 0061557521, 0061559077, 0061559628, 0061559631, 0061559852, 0061559853, 0061559854, 0061560830, 0061560831, 0061562493, 0061562494, 0061562941, 0061563541, 0061564175, 0061564176, 0061564177, 0061564179, 0061564180, 0061564431, 0061564669, 0061564670, 0061564672, 0061564673, 0061566362, 0061566363, 0061567272, 0061567809, 0061567810, 0061567811, 0061567812, 0061567813, 0061567814, 0061571324, 0061571325, 0061571326, 0061571327, 0061572464, 0061572465, 0061572466, 0061572980, 0061572981, 0061572982, 0061572983, 0061572984, 0061572985, 0061572987, 0061579647, 0061579648, 0061579651, 0061579653, 0061579654, 0061581522, 0061581585, 0061581586, 0061581590, 0061581599, 0061581602, 0061581603, 006158

code_info

0061546906, 0061546910, 0061548145, 0061548146, 0061548476, 0061548477, 0061548478, 0061548479, 0061548…

0061546906, 0061546910, 0061548145, 0061548146, 0061548476, 0061548477, 0061548478, 0061548479, 0061548645, 0061555100, 0061555101, 0061555102, 0061556350, 0061557521, 0061559077, 0061559628, 0061559631, 0061559852, 0061559853, 0061559854, 0061560830, 0061560831, 0061562493, 0061562494, 0061562941, 0061563541, 0061564175, 0061564176, 0061564177, 0061564179, 0061564180, 0061564431, 0061564669, 0061564670, 0061564672, 0061564673, 0061566362, 0061566363, 0061567272, 0061567809, 0061567810, 0061567811, 0061567812, 0061567813, 0061567814, 0061571324, 0061571325, 0061571326, 0061571327, 0061572464, 0061572465, 0061572466, 0061572980, 0061572981, 0061572982, 0061572983, 0061572984, 0061572985, 0061572987, 0061579647, 0061579648, 0061579651, 0061579653, 0061579654, 0061581522, 0061581585, 0061581586, 0061581590, 0061581599, 0061581602, 0061581603, 006158

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2343-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.