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U.S. Department of Health and Human Services

Class 2 Device Recall Coopersurgical

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 Class 2 Device Recall Coopersurgicalsee related information
Date Initiated by FirmJune 03, 2020
Create DateJuly 04, 2020
Recall Status1 Terminated 3 on May 11, 2021
Recall NumberZ-2498-2020
Recall Event ID 85787
Product Classification dilator, cervical, synthetic, osmotic, pregnancy termination - Product Code LOB
ProductCOOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
Code Information Lot 284288 - Expiration date: 02/24/2023
FEI Number 1216677
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information ContactCustomer Service
203-601-9818
Manufacturer 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
FDA Determined
Cause 2		Labeling design
ActionCooper Surgical issued letter dated 6/3/20/20 via Certified Mail stating reason for recall, health risk and action to take: Please discontinue use of and quarantine Products with any packaging irregularities, complete the attached Acknowledgement and Receipt Form, and return it to CooperSurgical. Once we receive the Acknowledgement Form, we will arrange for Product replacements and returns of affected Product. The replacement Products will be charged at the same price as the original order and your account will be credited back once the affected Products are returned to CooperSurgical. If you do not have affected Product in inventory, please use the same enclosed Form to indicate that and return it to CooperSurgical so that we may document receipt of this Recall Notice. CooperSurgical contact:: 203-601-5200 ext. 3300.
Quantity in Commerce2,250 units (45 boxes of 50)
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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