Device product

Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector.

Z-0785-2020

August 07, 2019

Class II

Product summary

Firm: Intersurgical Inc
Event: Event 83527
Status: Terminated
Classification: Class II
Quantity: 46,450 pieces
Official record key: device-enforcement:Z-0785-2020

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: 2180448, 2180742, 2181001

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.