FDA recall Z-0898-2022

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.

Reason for recall

Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.

Distribution

US Nationwide Distribution was made to KY, OK, and TX. There was no foreign/government/military distribution.

Key facts

Status
Terminated
Initiation date
2022-03-04
Report date
2022-04-13
Termination date
2023-03-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0898-2022