Device product
Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Z-2758-2017
Product summary
- Event
- Event 77686
- Status
- Terminated
- Classification
- Class II
- Quantity
- 528 each
- Official record key
device-enforcement:Z-2758-2017
Official wording
Reason: Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.
Code information: Lot 16LUS317, expires November 1, 2021
Distribution pattern: Worldwide Distribution - US (Nationwide including PR) and Canada
Derived failure modes
-
Unknown
Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.