Device product

Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.

Z-0786-2020

August 07, 2019

Class II

Product summary

Firm: Intersurgical Inc
Event: Event 83527
Status: Terminated
Classification: Class II
Quantity: 19,200 pieces
Official record key: device-enforcement:Z-0786-2020

Official wording

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.

Code information: Lot numbers: 2180531, 2181808, 2182241, 2182533

Distribution pattern: US Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.