Instrumentation Industries Recalls Ventilator Tubing Due to Delamination Risk
Instrumentation Industries Inc is recalling specific lots of reusable ventilator tubing due to a manufacturing defect that may cause layer delamination and leakage.
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 involves a medical device with a potential for leakage due to delamination, which poses a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Instrumentation Industries Inc is recalling 567 units of KC 036, KC 060, and KC 072 reusable ventilator tubing. The recall is initiated because of a possible manufacturing defect where the layers of the tube wall may delaminate. If delamination occurs, it would result in leakage.
The affected tubing was distributed worldwide, including in the United States (Pennsylvania, Florida, Georgia, Washington, Ohio, California, and Kansas) and internationally to Canada. The specific lot numbers involved are P0614015, P0818215, and P0825515 for KC 036; P0511915 and P0608315 for KC 060; and P0618415 and P0818515 for KC 072.
Consumers and healthcare facilities should check their inventory for these specific model and lot numbers. If the product is found, it should be removed from service and returned to the distributor or manufacturer according to their instructions.
The recalled product
- Product
- Ventilator Tubing
- Manufacturer
- Instrumentation Industries Inc
- Affected units
- 567
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 (5)
- Model Length Lot Numbers KC 036 36 tube P0614015
- P0818215
- P0825515 KC 060 60 tube P0511915
- P0608315 KC 072 72 tube P0618415
- P0818515
Distribution
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