Reported Jan 6, 2021 · Terminated
Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems;…
Intersurgical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intersurgical Inc · 6757 Kinne St · East Syracuse, NY · 13057-1215
Is this the product you have?
- Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia
- Breathing Systems - Product Usageintended 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
- Lot codes and dates
- Model NumberB0062001
- Lot Numbers4200283
- and 4200286 UDI Codes(01)00081647202239(10)4200286 (01)00081647202239(10)4200283
- Amount recalled
- 200 devices
Why it was recalled
The device was assembled with the incorrect exhalation port which can cause gas leakage.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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