The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0787-2020·Announced 2020-01-15

Intersurgical Airway Connector Recalled for Potential Swivel Elbow Cracking

Intersurgical Inc is recalling 50,400 airway connectors because the swivel elbow port may crack and leak. The recall covers products distributed nationwide in the US.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involves a medical device with a structural defect that could lead to leakage, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Intersurgical Inc is recalling 50,400 pieces of the Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port (REF 3521000). This airway connector was distributed nationwide in the United States. The affected lot numbers are 2182536, 2182852, 2183161, 2190350, 2190531, 2190617, 2191025, and 2191591.

The recall is being conducted 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. The source text does not report any specific injuries or illnesses associated with this defect.

Healthcare providers and facilities should check their inventory for the specific reference number and lot numbers listed above. If the product is found, it should be removed from use and returned to Intersurgical Inc in accordance with the recall instructions.

The recalled product

Product
Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.
Manufacturer
Intersurgical Inc
Category
Medical Device — Airway Connector
Hazard
Affected units
50,400

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 (8)

  • Lot numbers: 2182536
  • 2182852
  • 2183161
  • 2190350
  • 2190531
  • 2190617
  • 2191025
  • 2191591

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.

See all 4 products in this recall →

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