TELEFLEX LLC: Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equ

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: 60,500 units US Lot/code info: a) 19211, UDI: (01)04026704347995(17)250528(10)19LT34, (01)04026704347995(17)250528(10)20FT02, (01)04026704347995(17)250528(10)20FT03, (01)04026704347995(17)250528(10)20FT06, (01)04026704347995(17)250528(10)20FT07, (01)04026704347995(17)250528(10)20FT13, (01)04026704347995(17)250528(10)20FT14, (01)04026704347995(17)250528(10)20FT16, (01)04026704347995(17)250528(10)20FT20, (01)04026704347995(17)250528(10)20FT22, (01)04026704347995(17)250528(10)20FT38, (01)04026704347995(17)250528(10)20FT41, (01)04026704347995(17)250528(10)20FT42, (01)04026704347995(17)250528(10)20FT50, (01)04026704347995(17)250528(10)20FT51, (01)04026704347995(17)250528(10)20FT56, (01)04026704347995(17)250528(10)20FT57, (01)04026704347995(17)250528(10)20FT62, (01)04026704347995(17)250528(10)20FT63, (01)04026704347995(17)250628(10)20FT67, (01)04026704347995(17)250628(10)20GT02, (01)04026704347995(17)250628(10)20GT03, (01)04026704347995(17)250628(10)20GT15, (01)04026704347995(17)250628(10)20GT17, (01)04026704347995(17)250628(10)20GT20, (01)04026704347995(17)250628(10)20GT21, (01)04026704347995(17)250628(10)20GT27, (01)04026704347995(17)250628(10)20GT28, (01)04026704347995(17)250628(10)20GT39, (01)04026704347995(17)250628(10)20GT46, (01)04026704347995(17)250628(10)20GT48, (01)04026704347995(17)250628(10)20GT53, (01)04026704347995(17)250628(10)20GT55, (01)04026704347995(17)250628(10)KMH20G0002, (01)04026704347995(17)250628(10)KMH20G0003, (01)04026704347995(17)250628(10)KMH20G0004, (01)04026704347995(17)250628(10)K

UPC codes

04026704347995

Source

Official record: FDA (Device enforcement) ↗

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