Home / Recalls / CooperSurgical, Inc. / Z-0223-2023

Z-0223-2023 Class II Ongoing

Recalled by CooperSurgical, Inc. — Trumbull, CT

Recall Details

Product Type
Devices
Report Date
November 16, 2022
Initiation Date
October 20, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
220,500 devices

Product Description

NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540

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.

Distribution Pattern

Worldwide 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.

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

Other recalls by CooperSurgical, Inc.

  • Z-2136-2025 Class II — Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Conven (June 11, 2025)
  • Z-2135-2025 Class II — HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use i (June 11, 2025)
  • Z-2137-2025 Class II — Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endose (June 11, 2025)
  • Z-0688-2025 Class II — Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K (November 15, 2024)
  • Z-0690-2025 Class II — Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K2 (November 15, 2024)
  • Z-0689-2025 Class II — Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K2 (November 15, 2024)
  • Z-0692-2025 Class II — Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Mul (November 15, 2024)
  • Z-0687-2025 Class II — Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Numbe (November 15, 2024)
  • Z-0691-2025 Class II — Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 (November 15, 2024)
  • Z-3188-2024 Class II — Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 (July 31, 2024)