Z-0898-2022 Class II Terminated
FDA device recall Z-0898-2022 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Mar 4, 2022 and is designated Class II. 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. The recall status is terminated (terminated Mar 20, 2023). Affected quantity: 7,800 pouched syringes.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 13, 2022
- Initiation Date
- Mar 4, 2022
- Termination Date
- Mar 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0898-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026