Recall Z-1934-2013 ยท MMO Tray, Surgical, Ent
Medtronic Xomed, Inc.
Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.
| Date | Aug 9, 2013 (initiated Jul 9, 2013) |
| Status | Terminated |
| Reason | The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY" |
| Root cause | Device Design |
| Action | Medtronic sent a Customer Commincation Recall Letter to all affected customers with the following information: Subject: URGENT PRODUCT Recall Immediate Attention Required MEDTRONIC XOMED INSTRUMENT TRAYS - model numbers provided on Attachment One - all lots distributed prior to July 2013 Dear Purchasing Manager, Risk Manager and Central Supply Manager/Supervisor: This letter is to inform you that Medtronic Surgical Technologies (ENT Division) is initiating a voluntary recall to remove certain instrument trays from the field and replace them with trays that have modified labeling. Medtronic |
| Quantity | 3,562 trays |
| Distribution | Worldwide Distribution - USA (nationwide) Nationwide, Hawaii, Puerto Rico and Guam. Internationally to: Canada, Austria, Belgium, Cyprus, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Morocco, Netherlands, Nigeria, Portugal, Qatar, Reunion, Saudi Arabia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.