Z-2948-2018 Class II Terminated
FDA device recall Z-2948-2018 was initiated by Medline Industries Inc on Feb 1, 2018 and is designated Class II. Reason for recall: Packaged with an incorrect overwrap. The recall status is terminated (terminated Oct 5, 2020). Affected quantity: 90,870 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 5, 2018
- Initiation Date
- Feb 1, 2018
- Termination Date
- Oct 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90,870 units
Product Description
Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
Reason for Recall
Packaged with an incorrect overwrap.
Distribution Pattern
US Nationwide Distribution to states of: CA, CT, DE, FL, GA, IN, LA, MA, MD, MN, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA and WV
Code Information
Lot # 3131591
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2948-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026