The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths
- Company
- Medtronic Xomed, Inc.
- Recall Initiated
- January 29, 2004
- Posted
- July 20, 2004
- Terminated
- May 3, 2012
- Recall Number
- Z-0954-04
- Quantity
- 7 boxes, 5 sheaths per box
- Firm Location
- Jacksonville, FL
Reason for Recall
The sheaths in question have shafts that are one inch longer than required for the endoscope specified on the label.
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.
Lot / Code Info
Lots 31396400 and 30722300
Root Cause
Other
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.
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