Recall Z-0787-2020— Intersurgical Inc
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: K911421. Product: Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. 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 recordK-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
Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. 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.