Recall Z-2948-2018
Medline Industries Inc · initiated February 1, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
Codes / lots: Lot # 3131591
Reason for recall
Packaged with an incorrect overwrap.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-2948-2018
- Initiated
- February 1, 2018
- Terminated
- October 5, 2020
- Product code
- NGT – Saline, Vascular Access Flush
- Quantity
- 90,870 units
- Distribution
- 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
- Recalling firm
- Medline Industries Inc, Northfield, IL