Intersurgical Inc Recall 86800
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.
Intersurgical Inc Recall 86800 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0753-2021 |
| Event ID | 86800 |
| Event 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. |
| Product Type | Devices |
| Distribution | All of the devices were shipped to the same distributor (McKesson). |
| Quantity | 200 devices |
| Recall Reason | The device was assembled with the incorrect exhalation port which can cause gas leakage. |
| Device Classification | 20210106 |
| Device Code Info | Model Number: B0062001 Lot Numbers: 4200283 and 4200286 UDI Codes: (01)00081647202239(10)4200286 (01)00081647202239(10)4200283 |
| Center Classification Date | 20201230 |
| Recall Initiation Date | 20201111 |
| Recalling Firm | Intersurgical Inc |
| Initial Notification | |
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