Intersurgical Smoothbore Breathing System Recalled for Incorrect Exhalation Port
Intersurgical Inc is recalling 200 Smoothbore breathing systems with exhalation port 22 mm because they were assembled with the incorrect port, which can cause gas leakage.
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 defect (gas leakage) that poses a risk of harm to patients during anesthesia, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Intersurgical Inc is recalling 200 units of the Smoothbore breathing system with exhalation port 22 mm (Device REF #: B0062001). The affected products are Custom Anasthesia Breathing Systems and Multipac Anasthesia Breathing Systems intended to administer medical gases to a patient during anesthesia.
The recall was initiated because the devices were assembled with the incorrect exhalation port, which can cause gas leakage. The specific lot numbers involved are 4200283 and 4200286. All 200 devices were shipped to the same distributor, McKesson.
Healthcare providers and distributors should stop using the affected devices immediately. Consumers and medical facilities should contact Intersurgical Inc or their distributor for further instructions on how to handle the recalled units.
The recalled product
- Product
- 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…
- Manufacturer
- Intersurgical Inc
- Affected units
- 200
Distribution
Distribution scope not specified by the agency.
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