CLASS II Device recall · Reported 6 Jan 2021 · FDA Enforcement Report
Smoothbore breathing system with exhalation port Device recalled
Intersurgical is recalling Smoothbore breathing system with exhalation port Device. The recall was initiated on 11 Nov 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0753-2021
- FDA event ID
- 86800
- Recalling firm
- Intersurgical, East Syracuse, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Nov 2020
- FDA classified
- 30 Dec 2020
- Reported
- 6 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 11 Nov 2020 | Recall initiated by company | |
| 30 Dec 2020 | Classified by FDA | +49 days |
| 6 Jan 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device was assembled with the incorrect exhalation port which can cause gas leakage.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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 exhalation route and may include a connector, adaptor, and Y-piece.
Where it was distributed
All of the devices were shipped to the same distributor (McKesson).
Questions about this recall
Why was it recalled?
The device was assembled with the incorrect exhalation port which can cause gas leakage.
Which lots are affected?
Model Number: B0062001 Lot Numbers: 4200283 and 4200286 UDI Codes: (01)00081647202239(10)4200286 (01)00081647202239(10)4200283
Where was it sold?
All of the devices were shipped to the same distributor (McKesson).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Intersurgical
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|---|---|---|---|---|---|
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