Recall Z-0954-04 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Medtronic Xomed, Inc.
The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths
| Date | Jul 20, 2004 (initiated Jan 29, 2004) |
| Status | Terminated |
| Reason | The sheaths in question have shafts that are one inch longer than required for the endoscope specified on the label. |
| Root cause | Other |
| Action | A Recall notification letter was mailed to each hospital account on January 29, 2004 for each type of device they received which was under recall explaining the error and asking the accounts to remove recalled product from inventory, fax them the response sheet and to return the products. |
| Quantity | 7 boxes, 5 sheaths per box |
| Distribution | Products were distributed to 23 hospitals and surgical centers in NC, NB, IN, UT, TX, NY, WI, MO, TN, ID, OK, FL, MA, WY, NJ, LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982594 | ENDO-SCRUB/ENDO-SCRUB 2 Xomed, Inc., Aug 27, 1998 |