Recall Z-2798-2011 ยท FMI Needle, Hypodermic, Single Lumen
Terumo Medical Corporation
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.
| Date | Jul 13, 2011 (initiated Jun 8, 2010) |
| Status | Terminated |
| Reason | Hypodermic needle packaging defect could compromise sterility. Affected lot numbers are: MC1725, MC2025, MC2025 |
| Root cause | Packaging |
| Action | 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 |
| Quantity | 453,000 needles |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K771203 | DISP. HYPODERMIC NEEDLE Terumo America, Inc., Jul 14, 1977 |