FDA Device recall Z-0075-2023
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only
- FDA Device
- Class I
- ongoing
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class I recall of Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only by Teleflex, citing incidents of device splitting or detaching during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0075-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-08-29 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Teleflex |
| Distribution | US |
Product
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,
Reason
Incidents of device splitting or detaching during use
Identifiers
| code_info | a) 19261T, UDI: (01)04026704400492(17)250528(10)20FT51, (01)04026704400492(17)251028(10)KMH20L0409, (01)040267044004…a) 19261T, UDI: (01)04026704400492(17)250528(10)20FT51, (01)04026704400492(17)251028(10)KMH20L0409, (01)04026704400492(17)251228(10)KMH21A0086, (01)04026704400492(17)251228(10)KMH21A0190, (01)04026704400492(17)260128(10)KMH21B0163, (01)04026704400492(17)260128(10)KMH21B0343, (01)04026704400492(17)260128(10)KMH21B0355, (01)04026704400492(17)260228(10)KMH21C0177, (01)04026704400492(17)260228(10)KMH21C0387, (01)04026704400492(17)260528(10)KMH21F0156, (01)04026704400492(17)260528(10)KMH21F0337, (01)04026704400492(17)260628(10)KMH21G0426, (01)04026704400492(17)260828(10)KMH21J0020, (01)04026704400492(17)260828(10)KMH21J0245, (01)04026704400492(17)260928(10)KMH21K0142, (01)04026704400492(17)261128(10)KMH21M0182, (01)04026704400492(17)270128(10)KMH22B0151, (01)04026704400492(17)270128(10)KMH22B0248; b) 19262T, UDI: (01)04026704400508(17)250528(10)202025, (01)04026704400508(17)250528(10)202026, (01)04026704400508(17)250628(10)202030, (01)04026704400508(17)250828(10)KMZ20J0163, (01)040267 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0075-2023%22
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