FDA recall Z-1113-2021

Product

Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package.

Reason for recall

There is the potential of a bent or disconnected needle in one of the components of the convenience kits.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2020-12-23

Report date

2021-02-24

Termination date

2024-07-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Harrisburg, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1113-2021