Product Wiki · Recalls · U.S. FDA — Device Enforcement

Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector. — recall Z-0785-2020

U.S. FDA — Device Enforcement · United States · 2019-08-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0785-2020
Date of alert
2019-08-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Intersurgical Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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