Recall Z-0075-2023 ยท CAH Filter, Bacterial, Breathing-Circuit
TELEFLEX LLC
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,
| Date | Oct 14, 2022 (initiated Aug 29, 2022) |
| Status | Open, Classified |
| Reason | Incidents of device splitting or detaching during use |
| Root cause | Under Investigation by firm |
| Action | Teleflex, Inc. sent an URGENT MEDICAL DEVICE RECALL notice by Fedex 2-day mail on 08/29/2022. the notice described the problem, listed the complaints and requested the following actions be taken: Medical facilities: 1. Immediately check your inventory for product within the scope of this recall. Cease use and distribution of affected product and immediately quarantine the affected product. 2. If you have impacted product, mark the applicable checkbox on the Acknowledgement Form and contact Teleflex Customer Service by calling the phone number provided. Teleflex Customer Service will issue |
| Quantity | 355 units |
| Distribution | US nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K965016 | ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) Gibeck, Inc., Dec 2, 1997 |