COOPERSURGICAL Os FinderTM Cervical Dilator recall: Labeling Error
COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
Why was COOPERSURGICAL Os FinderTM Cervical Dilator 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 284288 - Expiration date: 02/24/2023
- 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
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 2,250 units (45 boxes of 50)
- Distribution
- Nationwide
- Recall date
- July 15, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)