Z-2343-2018 Class II Terminated
FDA device recall Z-2343-2018 was initiated by B. Braun Medical, Inc. on Jun 4, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jan 13, 2020). Affected quantity: 12320.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 11, 2018
- Initiation Date
- Jun 4, 2018
- Termination Date
- Jan 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12320
Product Description
26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550
Reason for Recall
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.
Distribution Pattern
The products were distributed to the following US states: AL, CA, CO, CT, FL, GA, IL, LA, MA, MD, MI, MN, MO, NC, NJ, NV, OH, PA, TX, and WA.
Code Information
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, 0061581982, 0061581983, 0061581984, 0061581985, 0061581986, 0061581987, 0061581988, 0061583281, 0061583282, 0061583283, 0061586220, 0061586221, 0061586222, 0061586223, 0061586224, 0061586712, 0061586713, 0061586714, 0061587151, 0061587152, 0061587153, 0061587154, 0061587155, 0061587156, 0061587157, 0061587720, 0061590070, 0061591603, 0061591618, 0061591646, 0061591660, 0061591662, 0061591663, 0061591664, 0061591665, 0061591667, 0061591675, 0061594365, 0061594366, 0061594367, 0061594368, 0061594369, 0061599040, 0061599159, 0061599160, 0061599161, 0061599162, 0061599163, 0061599164, 0061599165, 0061603919, 0061603920, 0061603921, 0061608039, 0061614625, 0061614626, 00VL559752
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2343-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026