Recall Z-0753-2021 ยท OFP Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Intersurgical Inc
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.
| Date | Nov 11, 2020 |
| Status | Terminated |
| Reason | The device was assembled with the incorrect exhalation port which can cause gas leakage. |
| Root cause | Process control |
| Action | Recall Strategy and Instruction: 1. Immediately discontinue use and quarantine any stock with the product/lot number described above in this recall notification. 2. If you have distributed any of these products, please immediately contact your customers, advise them of the recall situation and have them return their outstanding recalled stock to you. 3. Complete the Customer Product Recall Acknowledgement Form a. Return the completed form via email to Intersurgical Inc. at mhovey@intersurgicalinc.com. b. The subject line should contain Intersurgical Recall: Company name |
| Quantity | 200 devices |
| Distribution | All of the devices were shipped to the same distributor (McKesson). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.