Intersurgical Double Swivel Elbow Airway Connectors Recalled for Potential Cracking
Intersurgical Inc is recalling 46,450 Double Swivel Elbow airway connectors because the port may crack and leak.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (airway connector) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Intersurgical Inc is recalling 46,450 pieces of the Double Swivel Elbow with Bronchoscopy Port (REF 1996030). The affected lots are 2180448, 2180742, and 2181001. These airway connectors were distributed nationwide in the United States.
The recall was initiated because the port may crack in the swivel elbow where the flip cap is inserted. If these cracks reach a significant size, they could possibly leak. This is classified as an FDA Class II recall.
Healthcare facilities and consumers should stop using the affected products and contact Intersurgical Inc for instructions on return or replacement.
The recalled product
- Product
- Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector.
- Manufacturer
- Intersurgical Inc
- Affected units
- 46,450
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot numbers: 2180448
- 2180742
- 2181001
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Intersurgical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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