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Recall Observatory FDA recall evidence

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

February 01, 2018

Class II

Product summary

Firm
Medline Industries Inc
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

    reason.no_named_rule · v1.0.0

    Packaged with an incorrect overwrap.