Z-0898-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2022
- Initiation Date
- March 4, 2022
- Termination Date
- March 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,800 pouched syringes
Product Description
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 Pattern
US Nationwide Distribution was made to KY, OK, and TX. There was no foreign/government/military distribution.
Code Information
Lot #3139133, Exp. 11/01/2022.