FDA recall Z-2343-2018

Product

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

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.

Key facts

Status

Terminated

Initiation date

2018-06-04

Report date

2018-07-11

Termination date

2020-01-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2343-2018