Recall Z-2469-2012 ยท GBX Catheter, Irrigation
Linvatec Corp. dba ConMed Linvatec
Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.
| Date | Sep 27, 2012 (initiated Jul 1, 2011) |
| Status | Terminated |
| Reason | ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)because there is a possibility that the product may have a breach in the Tyvek seal that could potentially compromise the sterility of the contents. |
| Root cause | Employee error |
| Action | ConMed Linvatec sent a Urgent Medical Device Recall Notification via FedEx to all affected customers. This notice should be received July 5, 2011. The letter identified the product the problem and the action needed to be taken by the customer. All returned product under this removal action will be identified, segregated, and quarantined per ConMed Utica, N.Y. procedures. Returned product will be dispositioned in accordance with ConMed Utica, N.Y. procedures. This can include repackaged and resterilization with new lot number or product scrap. ConMed Utica, N.Y. will maintain control of al |
| Quantity | 30064 units |
| Distribution | Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA ,WI and Hawaii., and the countries of Australia Canada, China, Switzerland, Germany, Czech Republic, Denmark, E |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.