Recall Z-0753-2021— Intersurgical Inc
Class II · Terminated
Class II FDA medical device recall by Intersurgical Inc, initiated 2020-11-11, terminated 2022-08-09. FDA's recall record names no specific 510(k) clearance for this event. 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 exhalation route and may include a connector, adaptor, and Y-piece.. Reason: The device was assembled with the incorrect exhalation port which can cause gas leakage..
- Recalling firm
- Intersurgical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-11
- Terminated
- 2022-08-09
- Firm location
- East Syracuse, NY, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.