FDA-Device2020-07-15Class II
COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
CooperSurgical, Inc.
Hazard
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
Sold states
Nationwide
Affected count
2,250 units (45 boxes of 50)
Manufactured in
95 Corporate Dr, Trumbull, CT, United States
Products
COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2498-2020Don't want to check this manually?
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