Recall Z-2886-2011 ยท FAQ Bag, Urine Collection, Leg, For External Use, Sterile
Teleflex Medical
***** EXPANDED RECALL ***** Rusch Foley Catheter Insertion Tray with Preconnected Bag and 16 Fr. Catheter, Manufactured for and distributed by Teleflex Medical, Research Triangle Park, NC 57708 Product Usage: For one time use per the Directions for Use with urinary catheter for drainage of urine.
| Date | Jun 27, 2011 (initiated Jun 2, 2011) |
| Status | Terminated |
| Reason | Sterile integrity cannot be guaranteed. |
| Root cause | Other |
| Action | Teleflex Medical sent an " URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 2, 2011. The letter identified the product, the problem and the actions needed to be taken. The customers were instructed to immediately discontinue distribution, quarantine any affected products, communicate this recall to any of their customers using the provided customer letter, and complete and fax the enclosed Recall Acknowledgement Form to Customer Service at 1-866-804-9881. Once the fax is received instructions for product return will be provided to customers. In the event that an alternative app |
| Quantity | see line 1. |
| Distribution | Nationwide Distribution: AZ, CA, FL, GA, IL, KS, KY, LA, MA, MS, NC, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WI including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.