FDANovember 11, 2020device
Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and ma...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The device was assembled with the incorrect exhalation port which can cause gas leakage.
What to do
FDA enforcement status: Terminated
Brands named
intersurgical
UPCs
00081647202239
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOne-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.2025-06-20
- FDAOne-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.2025-06-20
- FDAi-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.2025-06-17
- FDAIntersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 80030002022-08-29
- FDASuperset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.2019-08-07
- FDASuperset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.2019-08-07
- FDADouble Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.2019-08-07
- FDADouble Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector.2019-08-07
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