Recall Z-1897-2011 ยท KMJ Lubricant, Patient
Teleflex Medical
Rusch Irrigation Tray w/Bulb Catalogue Number 68895 For irrigation according to institutional guidelines.
| Date | Apr 5, 2011 (initiated Feb 24, 2011) |
| Status | Terminated |
| Reason | The irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by Triad Group, due to a potential bacterial contamination. |
| Root cause | Other |
| Action | the firm,Teleflex Medical, sent two "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letters one dated February 24, 2011 and the other dated March 30, 2011 to all consignees and customers. The letters described the product, problem and actions to be taken. The consignees were instructed to communicate the recall to any of their customers who have received product included within the scope of the field corrective action via the customer letter. The customers were informed in the letter of concerns about potential bacterial contamination of the alcohol prep pads in the affected trays. If contaminat |
| Quantity | see line 1. |
| Distribution | Worldwide distribution: USA including states of: AL, AZ, CA, FL, GA, IL, MS, MI, MO, MS, NC, NJ, NH, NY, OH, PA, TX, UT, VA, Puerto Rica and the country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.