Recall Z-0787-2020 ยท BZA Connector, Airway (Extension)
Intersurgical Inc
Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.
| Date | Aug 7, 2019 |
| Status | Terminated |
| Reason | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size. |
| Root cause | Under Investigation by firm |
| Action | Intersurgical Inc. issued Urgent Medical Device Recall notices to customers dated August 5, 2019. Customers were advised to take the following actions: 1. Immediately discontinue use and quarantine any stock with the product/lot number described in the recall notification. 2. If you have distributed any of these products, please immediately contact your customers, advise them of the recall situation and have them return their outstanding recalled stock to you. 3. Contact Intersurgical Customer Support at 800-828-9633 for a Return Goods Authorization (RGA) Number. Hours of operation are M |
| Quantity | 50,400 pieces |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911421 | CATHETER MOUNTS Intersurgical, Inc., Jun 24, 1991 |