Recall Z-0223-2023— CooperSurgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by CooperSurgical, Inc., initiated 2022-10-20. FDA's recall record names no specific 510(k) clearance for this event. Product: NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540. Reason: 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..
- Recalling firm
- CooperSurgical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-10-20
- Firm location
- Trumbull, CT, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.