Recall Z-0784-2020— Intersurgical Inc

Name: FDA recall Z-0784-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-07

Class II · Terminated

Class II FDA medical device recall by Intersurgical Inc, initiated 2019-08-07, terminated 2020-12-15. It names one FDA 510(k) clearance: K911425. Product: Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.. 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..

Recalling firm: Intersurgical Inc
Classification: Class II
Status: Terminated
Initiated: 2019-08-07
Terminated: 2020-12-15
Firm location: East Syracuse, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K911425 — ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MMIntersurgical, Inc.·cleared 1991-06-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.