PlainRecalls
FDA Devices Moderate Class II Terminated

COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176

Reported: July 15, 2020 Initiated: June 3, 2020 #Z-2498-2020

Product Description

COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176

Reason for Recall

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

Details

Recalling Firm
CooperSurgical, Inc.
Units Affected
2,250 units (45 boxes of 50)
Distribution
Nationwide
Location
Trumbull, CT

Frequently Asked Questions

What product was recalled?
COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176. Recalled by CooperSurgical, Inc.. Units affected: 2,250 units (45 boxes of 50).
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on July 15, 2020. Severity: Moderate. Recall number: Z-2498-2020.