Z-0753-2021 Class II Terminated
FDA device recall Z-0753-2021 was initiated by Intersurgical Inc on November 11, 2020 and is designated Class II. Reason for recall: The device was assembled with the incorrect exhalation port which can cause gas leakage. The recall status is terminated (terminated August 9, 2022). Affected quantity: 200 devices.
Recall Details
- Product Type
- Devices
- Report Date
- January 6, 2021
- Initiation Date
- November 11, 2020
- Termination Date
- August 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 devices
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.
Distribution Pattern
All of the devices were shipped to the same distributor (McKesson).
Code Information
Model Number: B0062001 Lot Numbers: 4200283 and 4200286 UDI Codes: (01)00081647202239(10)4200286 (01)00081647202239(10)4200283