Drug recall
Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing…
FDA recall event 86800 · Class II · Intersurgical Inc
Key facts
| Event ID | 86800 |
|---|---|
| Recall numbers | Z-0753-2021 |
| Recalling firm | Intersurgical Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device was assembled with the incorrect exhalation port which can cause gas leakage. |
| Initiation date | Nov 11, 2020 |
| Report date | Jan 6, 2021 |
| Termination date | Aug 9, 2022 |
| City | East Syracuse |
| State | NY |
| Country | United States |
| FEI number | 1000120301 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: