Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
FDA Recall Z-2948-2018 · Posted None
Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeNGT
Date Initiated2018-02-01
Date Terminated2020-10-05
Product Quantity90,870 units
Reason for Recall
Packaged with an incorrect overwrap.
Firm Action
The firm, Medline Industries, Inc., sent an "URGENT RECALL IMMEDIATE ACTION REQUIRED" letter dated February 1, 2018 to their consignees with the required actions to be followed;
1. Immediately check your stock for item number EMZ10051240 and the affected lot number, 3131591, and quarantine all affected product.
2. Please return the completed enclosed destruction form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form.
When we receive your completed destruction form your account will receive
replacement(s).
3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, Inc.
Should you have any questions, contact the Recall Coordinator at 1-866-359-1704.
Root Cause
Employee error
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.