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,

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: 355 units Lot/code info: 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)04026704400508(17)250828(10)KMZ20J0171, (01)04026704400508(17)250828(10)KMZ20J0582, (01)04026704400508(17)250828(10)KMZ20J0586, (01)04026704400508(17)250828(10)KMZ20J0587, (01)04026704400508(17)250928(10)KMZ20K0681, (01)04026704400508(17)251028(10)KMZ20L0968, (01)04026704400508(17)251028(10)KMZ20L0977, (01)04026704400508(17)251028(10)KMZ20L1275, (01)04026704400508(17)251128(10)KMZ20M0544, (01)04026704400508(17)251128(10)KMZ20M0661, (01)04026704400508(17)251228(10)KMZ21A0175, (01)04026704400508(17)251228(10)

UPC codes

04026704400492, 04026704400508, 04026704400515

Source

Official record: FDA (Device enforcement) ↗

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