Device product
COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
Z-2498-2020
Product summary
- Event
- Event 85787
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,250 units (45 boxes of 50)
- Official record key
device-enforcement:Z-2498-2020
Official wording
Reason: Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicating that it contains a Pipet Current or Part Number MX140 and the display box indicating the correct Os FinderTM Cervical Dilators, Part Number 1176. The product in the individual product package is the correct Os Finder Cervical Dilator
Code information: Lot 284288 - Expiration date: 02/24/2023
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Mislabeled