Home / Recalls / TELEFLEX LLC / Z-0074-2023

Z-0074-2023 Class I Ongoing

Recalled by TELEFLEX LLC — Morrisville, NC

FDA device recall Z-0074-2023 was initiated by TELEFLEX LLC on Aug 29, 2022 and is designated Class I. Reason for recall: Incidents of device splitting or detaching during use The recall status is ongoing. Affected quantity: 164 units.

Recall Details

Product Type: Devices
Report Date: Oct 26, 2022
Initiation Date: Aug 29, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 164 units

Product Description

Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use

Reason for Recall

Incidents of device splitting or detaching during use

Distribution Pattern

US nationwide distribution

Code Information

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)250628(10)202029, (01)04026704400485(17)250628(10)202030, (01)04026704400485(17)250728(10)KMZ20H0321, (01)04026704400485(17)250728(10)KMZ20H0341, (01)04026704400485(17)250728(10)KMZ20H0407, (01)04026704400485(17)250728(10)KMZ20H0519, (01)04026704400485(17)250728(10)KMZ20H0602, (01)04026704400485(17)250728(10)KMZ20H0619, (01)04026704400485(17)250728(10)KMZ20H0785, (01)04026704400485(17)250728(10)KMZ20H0792, (01)04026704400485(17)250728(10)KMZ20H0804, (01)04026704400485(17)250728(10)KMZ20H1025, (01)04026704400485(17)250728(10)KMZ20H1026, (01)04026704400485(17)250828(10)KMZ20J0386, (01)04026704400485(17)250828(10)KMZ20J0428, (01)04026704400485(17)250828(10)KMZ20J0466, (01)04026704400485(17)250828(10)KMZ20J0475, (01)04026704400485(17)250928(10)KMZ20K0161, (01)04026704400485(17)250928(10)KMZ20K0436, (01)04026704400485(17)250928(10)KMZ20K0478, (01)04026704400485(17)250928(10)KMZ20K0526, (01)04026704400485(17)250928(10)KMZ20K0527, (01)04026704400485(17)250928(10)KMZ20K0799, (01)04026704400485(17)250928(10)KMZ20K0917, (01)04026704400485(17)250928(10)KMZ20K1295, (01)04026704400485(17)250928(10)KMZ20K1311, (01)04026704400485(17)251028(10)KMZ20L0144, (01)04026704400485(17)251028(10)KMZ20L0160, (01)04026704400485(17)251028(10)KMZ20L0338, (01)04026704400485(17)251028(10)KMZ20L0350, (01)04026704400485(17)251028(10)KMZ20L0912, (01)04026704400485(17)251028(10)KMZ20L0926, (01)04026704400485(17)251028(10)KMZ20L0927, (01)04026704400485(17)251028(10)KMZ20L0928, (01)04026704400485(17)251028(10)KMZ20L0944, (01)04026704400485(17)251128(10)KMZ20M0411, (01)04026704400485(17)251128(10)KMZ20M1224, (01)04026704400485(17)251228(10)KMZ21A0011, (01)04026704400485(17)251228(10)KMZ21A0214, (01)04026704400485(17)251228(10)KMZ21A0301, (01)04026704400485(17)251228(10)KMZ21A0369, (01)04026704400485(17)251228(10)KMZ21A0419, (01)04026704400485(17)251228(10)KMZ21A0533, (01)04026704400485(17)251228(10)KMZ21A0807, (01)04026704400485(17)251228(10)KMZ21A0867, (01)04026704400485(17)251228(10)KMZ21A1017, (01)04026704400485(17)260128(10)KMZ21B0688, (01)04026704400485(17)260128(10)KMZ21B1032, (01)04026704400485(17)260128(10)KMZ21B1156, (01)04026704400485(17)260128(10)KMZ21B1188, (01)04026704400485(17)260228(10)KMZ21C0712, (01)04026704400485(17)260228(10)KMZ21C0760, (01)04026704400485(17)260228(10)KMZ21C0882, (01)04026704400485(17)260228(10)KMZ21C1163, (01)04026704400485(17)260228(10)KMZ21C1329, (01)04026704400485(17)260328(10)KMZ21D0390, (01)04026704400485(17)260328(10)KMZ21D0394, (01)04026704400485(17)260328(10)KMZ21D0400, (01)04026704400485(17)260328(10)KMZ21D0518, (01)04026704400485(17)260328(10)KMZ21D0534, (01)04026704400485(17)260328(10)KMZ21D1020, (01)04026704400485(17)260328(10)KMZ21D1051, (01)04026704400485(17)260428(10)KMZ21E0245, (01)04026704400485(17)260428(10)KMZ21E0253, (01)04026704400485(17)260428(10)KMZ21E0420, (01)04026704400485(17)260528(10)KMZ21F0202, (01)04026704400485(17)260528(10)KMZ21F0206, (01)04026704400485(17)260528(10)KMZ21F0217, (01)04026704400485(17)260528(10)KMZ21F0339, (01)04026704400485(17)260528(10)KMZ21F0438, (01)04026704400485(17)260528(10)KMZ21F0773, (01)04026704400485(17)260528(10)KMZ21F0786, (01)04026704400485(17)260628(10)KMZ21G0060, (01)04026704400485(17)260628(10)KMZ21G0353, (01)04026704400485(17)260628(10)KMZ21G0360, (01)04026704400485(17)260628(10)KMZ21G0392, (01)04026704400485(17)260728(10)KMZ21H0410, (01)04026704400485(17)260728(10)KMZ21H0424, (01)04026704400485(17)260728(10)KMZ21H0534, (01)04026704400485(17)260728(10)KMZ21H0538, (01)04026704400485(17)260828(10)KMZ21J0036, (01)04026704400485(17)260828(10)KMZ21J0321, (01)04026704400485(17)260828(10)KMZ21J0338, (01)04026704400485(17)260828(10)KMZ21J0403, (01)04026704400485(17)260828(10)KMZ21J0407, (01)04026704400485(17)260828(10)KMZ21J0428, (01)04026704400485(17)260828(10)KMZ21J0435, (01)04026704400485(17)260928(10)KMZ21K0028, (01)04026704400485(17)260928(10)KMZ21K0113, (01)04026704400485(17)260928(10)KMZ21K0191, (01)04026704400485(17)260928(10)KMZ21K0223, (01)04026704400485(17)260928(10)KMZ21K0230, (01)04026704400485(17)260928(10)KMZ21K0239, (01)04026704400485(17)260928(10)KMZ21K0260, (01)04026704400485(17)260928(10)KMZ21K0329, (01)04026704400485(17)260928(10)KMZ21K0381, (01)04026704400485(17)260928(10)KMZ21K0391, (01)04026704400485(17)260928(10)KMZ21K0403, (01)04026704400485(17)260928(10)KMZ21K0438, (01)04026704400485(17)260928(10)KMZ21K0457, (01)04026704400485(17)260928(10)KMZ21K0498, (01)04026704400485(17)260928(10)KMZ21K0552, (01)04026704400485(17)260928(10)KMZ21K0562, (01)04026704400485(17)260928(10)KMZ21K0579, (01)04026704400485(17)260928(10)KMZ21K0610, (01)04026704400485(17)261028(10)KMZ21L0114, (01)04026704400485(17)261028(10)KMZ21L0209, (01)04026704400485(17)261028(10)KMZ21L0321, (01)04026704400485(17)261028(10)KMZ21L0536, (01)04026704400485(17)261028(10)KMZ21L0665, (01)04026704400485(17)261128(10)KMZ21M0066, (01)04026704400485(17)261128(10)KMZ21M0476, (01)04026704400485(17)261128(10)KMZ21M0486, (01)04026704400485(17)261128(10)KMZ21M0526, (01)04026704400485(17)261128(10)KMZ21M0572, (01)04026704400485(17)261128(10)KMZ21M0586, (01)04026704400485(17)261128(10)KMZ21M0601, (01)04026704400485(17)261128(10)KMZ21M0606, (01)04026704400485(17)261128(10)KMZ21M0658, (01)04026704400485(17)261128(10)KMZ21M0742, (01)04026704400485(17)261128(10)KMZ21M0775, (01)04026704400485(17)261228(10)KMZ22A0035, (01)04026704400485(17)261228(10)KMZ22A0059, (01)04026704400485(17)261228(10)KMZ22A0076, (01)04026704400485(17)261228(10)KMZ22A0085, (01)04026704400485(17)261228(10)KMZ22A0471, (01)04026704400485(17)261228(10)KMZ22A0482, (01)04026704400485(17)261228(10)KMZ22A0483, (01)04026704400485(17)270128(10)KMZ22B0043, (01)04026704400485(17)270128(10)KMZ22B0044, (01)04026704400485(17)270128(10)KMZ22B0123, (01)04026704400485(17)270128(10)KMZ22B0439, (01)04026704400485(17)270128(10)KMZ22B0480, (01)04026704400485(17)270128(10)KMZ22B0783, (01)04026704400485(17)270128(10)KMZ22B0871, (01)04026704400485(17)270228(10)KMZ22C0231, (01)04026704400485(17)270228(10)KMZ22C0398, (01)04026704400485(17)270228(10)KMZ22C0444, (01)04026704400485(17)270228(10)KMZ22C0606, (01)04026704400485(17)270228(10)KMZ22C0611, (01)04026704400485(17)270228(10)KMZ22C0616, (01)04026704400485(17)270228(10)KMZ22C0624.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0074-2023
openFDA file date: Oct 6, 2026
Loaded by RegDataLab: Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.

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