FDA Device recall Z-0753-2021
Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems
- FDA Device
- Class II
- terminated
- Published 2021-01-06
On 2021-01-06 the FDA classified a Class II recall of Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems by Intersurgical, citing the device was assembled with the incorrect exhalation port which can cause gas leakage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0753-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-11 |
| Published | 2021-01-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Intersurgical |
| Distribution | n/a |
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.
Identifiers
| code_info | Model Number: B0062001 Lot Numbers: 4200283 and 4200286 UDI Codes: (01)00081647202239(10)4200286 (01)00081647202239(10)4200283 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0753-2021%22
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