Recall Z-1867-2021 ยท CAH Filter, Bacterial, Breathing-Circuit
Covidien, LP
Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
| Date | Jun 16, 2021 (initiated Apr 29, 2021) |
| Status | Open, Classified |
| Reason | The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization. |
| Root cause | Material/Component Contamination |
| Action | An Urgent Medical Device Field Safety Notice dated 4/29/21 was sent to customers. Actions you should take: 1. Immediately quarantine and discontinue use of item codes with associated lot numbers listed in Attachment A. 2. If you have distributed the devices listed in Attachment A, please promptly forward the information from this letter to those recipients. Actions being taken by Medtronic: 1. Medtronic is investigating the sterilization records for affected production lots to determine whether sterilization has been achieved despite the deviations. 2. Medtronic will communicate with affecte |
| Quantity | 7200 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K941536 | BARRIERBAC AND BARRIERBAC S Mallinckrodt Medical, Apr 19, 1994 |