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U.S. Department of Health and Human Services

Class 2 Device Recall Cooper Surgical

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 Class 2 Device Recall Cooper Surgicalsee related information
Date Initiated by FirmMarch 31, 2022
Date PostedDecember 06, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0502-2024
Recall Event ID 93239
510(K)NumberK961752 
Product Classification Cannula, manipulator/injector, uterine - Product Code LKF
ProductCooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes. Model: 61-3005
Code Information UDI-DI: 60888937016408 SN: 312868
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information ContactCustomer Service
203-601-9818
Manufacturer Reason
for Recall		Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure
FDA Determined
Cause 2		Component design/selection
ActionCooperSurgical issued Urgent Medical Device Safety Notice dated March 22, 2023 via UPS Certified Delivery Mail. Letter states reason for recall, health risk and action to take:Our records indicate that you may have purchased the affected Product from CooperSurgical. Please inspect stock and complete the attached Acknowledgement and Receipt Form. Once completed please return the form to CooperSurgical to acknowledge receipt of the notice. 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. A corrective action has been initiated to ensure this failure does not reoccur. We sincerely apologize for any inconvenience caused by this notice. CooperSurgical is committed to high quality, safe and effective products. Please feel free to reach us at 203-601-5200 ext. 3300 or via email at Recall@coopersurgical.com.
Quantity in Commerce73 units
DistributionNationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LKF
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