The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths
FDA device recall Z-0954-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Medtronic Xomed, Inc.
- Reason for recall
- The sheaths in question have shafts that are one inch longer than required for the endoscope specified on the label.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FED
- Quantity affected
- 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.
- Date initiated
- 2004-01-29
- Date posted
- 2004-07-20
- Date terminated
- 2012-05-03
- Location
- Jacksonville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDO-SCRUB/ENDO-SCRUB 2 (K982594) | Xomed, Inc. | 1998-08-27 |