Terumo(tm) Hypodermic Needle, sterile, individually packaged into a "blister-pack" flexible plastic bottom-web thermo-formed to create a pocket, heat-sealed with paper top-web,1,000 needles per case. Product Usage: Aspiration and injection of fluids for medical purposes.
This recall has been terminated (originally issued July 13, 2011).
- Company
- Terumo Medical Corporation
- Recall Initiated
- June 8, 2010
- Posted
- July 13, 2011
- Terminated
- July 14, 2011
- Recall Number
- Z-2798-2011
- Quantity
- 453,000 needles
- Firm Location
- Elkton, MD
- Official Source
- View on FDA website ↗
Reason for Recall
Hypodermic needle packaging defect could compromise sterility. Affected lot numbers are: MC1725, MC2025, MC2025
Distribution
Nationwide Distribution (USA) -- AZ, CA, CO, FL, GA, IL, KS, KY, MA, MO, NC, NJ, NY, OH, PA, TN, TX, WA, UT, and VA
Lot / Code Info
Catalog Number 431, Catalog Number 443, Catalog Number 100280
Root Cause
Packaging
Action Taken
The firm, Terumo Medical Corporation sent an "URGENT PRODUCT BULLETIN: RECALL OF TERUMO PRODUCT" letter dated June 8, 2010. Consignees were contacted via telephone on June 7 thru 9, 2010 to confirm receipt of the Product Recall Bulletin. The letter describes the product, problem and the actions to be taken. The letter instructed customers to immediately discontinue use and quarantine any available stock of the listed product codes. The letter stated that distributors must not distribute any of the listed product codes, quarantine any available stock and send the recall bulletin immediately to each customer that received the recalled products to inform them of this issue. Additionally, Terumo Medical Corporation sent a "Terumo Customer Instructions for Returning Recalled Product and Customer Confirmation of Product Recall Notification" letters dated June 8, 2010 to all affected facilities. Customers were instructed to fill-out the requested information and return to Terumo Medical Corporation (TMC) Product Recall Coordinator. Consignees were contacted via telephone on June 8 and 9, 2010 to confirm receipt of the recall information and compliance with the requested action. For questions or need for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator.