Intersurgical Flexible Breathing Circuit Recall Due to Exhalation Port Blockage Risk
Intersurgical Inc is recalling 1,340 Flexible Smoothbore Breathing Circuits because the tubing may block the exhalation port during assembly, posing a serious health risk to patients.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the defect could 'potentially pose a serious health risk to the patient,' which aligns with the rubric criterion for Severe (4) involving significant injury reports or high-risk medical device defects.
Plain-English summary
Intersurgical Inc is recalling 1,340 units of the Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall was initiated because when assembling a Heat and Moisture Exchanger (HME) or Filter on the breathing circuit, the tubing may be pushed up and inadvertently cover or block the exhalation port. This defect could potentially pose a serious health risk to the patient.
The affected products were distributed to distributors in Illinois, New Jersey, Nevada, Texas, and Utah. The specific lot codes involved are 0261604, 0671602, 0671603, 0741609, 0751601, 0821605, 0821606, 0891605, 0891606, 0951609, 0961601, 1751601, 0011802, 0011803, 0021803, 0081808, and 0161805. Healthcare providers and distributors should stop using the affected devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
- Manufacturer
- Intersurgical Inc
- Affected units
- 1,340
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 (16)
- 0261604
- 0671602
- 0671603
- 0741609
- 0751601
- 0821605
- 0821606
- 0891605
- 0891606
- 0951609
- 0961601
- 1751601
- 0011802
- 0011803
- 0021803
- 0081808 and 0161805.
Distribution
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