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U.S. Department of Health and Human Services

Class 2 Device Recall NEOfit

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 Class 2 Device Recall NEOfitsee related information
Date Initiated by FirmOctober 20, 2022
Date PostedNovember 10, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0223-2023
Recall Event ID 91047
Product Classification Support, breathing tube - Product Code JAY
ProductNEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
Code Information Lot/Serial Number UDI-DI (GTIN-14 - not yet added to GUDID database) 272992 00888937016659 269476 00888937016659 269477 00888937016659 269478 00888937016659 269479 00888937016659 269480 00888937016659 269482 00888937016659 269483 00888937016659 274957 00888937016659 274958 00888937016659 274960 00888937016659 274961 00888937016659 286859 00888937016659 286861 00888937016659 286863 00888937016659 292881 00888937016659 292883 00888937016659 292888 00888937016659 292889 00888937016659 292900 00888937016659 292901 00888937016659 292903 00888937016659 296236 00888937016659 296238 00888937016659 297033 00888937016659 297034 00888937016659 297035 00888937016659 298049 00888937016659 298055 00888937016659 298054 00888937016659 298056 00888937016659 298062 00888937016659 303771 00888937016659 303772 00888937016659 303950 00888937016659 304053 00888937016659 304363 00888937016659 305019 00888937016659 305020 00888937016659 307724 00888937016659 306339 00888937016659 306341 00888937016659 307728 00888937016659 307726 00888937016659 307730 00888937016659 308591 00888937016659 309910 00888937016659 309912 00888937016659 313142 00888937016659 311533 00888937016659 314675 00888937016659 315626 00888937016659 315810 00888937016659 318970 00888937016659 316866 00888937016659 320400 00888937016659
FEI Number 1216677
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information ContactDaniel Heuer
203-601-5200 Ext. 3300
Manufacturer Reason
for Recall		Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal clip was ingested by the patient, and 3 cases where the metal clip was removed from the patient's mouth. In one case, the patient suffered a laceration to the throat.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn October 20, 2022, the firm notified affected customers via "URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE" letters dated 10/7/2022. Customers were instructed to quarantine all affected product and complete the appropriate version of the attached form (Customer Acknowledgement Form or Distributor Acknowledgement Form). Once completed, return the form to CooperSurgical as indicated at the top of the form. Note: Even if you do not have any affected product in your inventory (or have not distributed any affected product to customers), please complete and return the enclosed form so that we may document receipt of this FSN. CooperSurgical will then arrange for the return of the affected product at no additional cost to the customer. Customers will receive a credit for returned product. If you have any questions, please feel free to reach us at 203-601-5200 ext. 3300 or recall@coopersurgical.com.
Quantity in Commerce220,500 devices
DistributionWorldwide distribution: US (Nationwide) including Puerto Rico; and countries (foreign) of: Australia, Bahrain, Belgium, Bulgaria, Canada, Colombia, Cyprus, Ecuador, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Malaysia, Malta, Netherlands, New Zealand, Saudi Arabia, Singapore, Turkey, Philippines, Qatar, United Arab Emirates, and United Kingdom.
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.
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