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

Hazard

Incidents of device splitting or detaching during use

Details from the source

Reason for recall: Incidents of device splitting or detaching during use Distribution: US nationwide distribution Quantity: 164 units Lot/code info: 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)

UPC codes

04026704400478, 04026704348008, 04026704400485

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.