FDA Device recall Z-0074-2023
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, 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, Tethered Cap, REF: a) 19211T, 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-0074-2023 |
| 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, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
Reason
Incidents of device splitting or detaching during use
Identifiers
| code_info | a) 19211T, UDI: (01)04026704400478(17)250528(10)20FT38, (01)04026704400478(17)250628(10)20FT63, (01)04026704400478(17)…a) 19211T, UDI: (01)04026704400478(17)250528(10)20FT38, (01)04026704400478(17)250628(10)20FT63, (01)04026704400478(17)250728(10)20GT03, (01)04026704400478(17)250828(10)KMH20H0303, (01)04026704400478(17)251028(10)KMH20J0148, (01)04026704400478(17)251028(10)KMH20L0135, (01)04026704400478(17)251028(10)KMH20L0137, (01)04026704400478(17)251128(10)KMH20L0362, (01)04026704400478(17)251128(10)KMH20M0236, (01)04026704400478(17)251128(10)KMH20M0276, (01)04026704400478(17)251228(10)KMH20M0477, (01)04026704400478(17)260228(10)KMH21A0397, (01)04026704400478(17)260828(10)KMH21C0228, (01)04026704400478(17)260928(10)KMH21J0146, (01)04026704400478(17)260928(10)KMH21K0122, (01)04026704400478(17)260928(10)KMH21K0130, (01)04026704400478(17)260928(10)KMH21K0133, (01)04026704400478(17)260928(10)KMH21K0137, (01)04026704348008(17)241128(10)KMH21K0155; b) 19212T, UDI: (01)04026704400485(17)250528(10)202025, (01)04026704400485(17)250528(10)202026, (01)04026704400485(17)250628(10)202027, (01)04026704400485(17 |
|---|
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-0074-2023%22
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