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

FDA device recall Z-0223-2023 · posted 2022-11-10 · Open, Classified

Recall details

Recalling firm

CooperSurgical, Inc.

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.

Action taken

On 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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JAY

Quantity affected

220,500 devices

Distribution

Worldwide distribution: US (Nationwide) including Puerto Rico; and countries (foreign) of: Australia, Bahrain, Belgium, Bulgaria, Canada, Colombia, Cyprus, Ecuador, Germany, Greece, Hong Kong, Hungary

Date initiated

2022-10-20

Date posted

2022-11-10

Location

Trumbull, CT