Device product
Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
Z-2948-2018
Product summary
- Event
- Event 80702
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90,870 units
- Official record key
device-enforcement:Z-2948-2018
Official wording
Reason: Packaged with an incorrect overwrap.
Code information: Lot # 3131591
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
Derived failure modes
-
Unknown
Packaged with an incorrect overwrap.