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.
Reported: January 6, 2021 Initiated: November 11, 2020 #Z-0753-2021
Product Description
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.
Reason for Recall
The device was assembled with the incorrect exhalation port which can cause gas leakage.
Details
- Recalling Firm
- Intersurgical Inc
- Units Affected
- 200 devices
- Distribution
- All of the devices were shipped to the same distributor (McKesson).
- Location
- East Syracuse, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Intersurgical Inc. Units affected: 200 devices.
Why was this product recalled? ▼
The device was assembled with the incorrect exhalation port which can cause gas leakage.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 6, 2021. Severity: Moderate. Recall number: Z-0753-2021.
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