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FDA (Device enforcement)Recalled 2022-08-29class i

TELEFLEX LLC: Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, 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: 7 units Lot/code info: a) 19261, UDI: (01)04026704388486(17)260128(10)KMH21B0193, (01)04026704388486(17)251028(10)KMH20L0234, (01)04026704388486(17)260828(10)KMH21J0246, (01)04026704388486(17)261028(10)KMH21L0294, (01)04026704388486(17)261228(10)KMH22A0230; b) 19272, UDI: (01)04026704388509(17)260428(10)KMZ21E0613, (01)04026704388509(17)260528(10)KMZ21F0939

UPC codes

04026704388486, 04026704388509

Source

Official record: FDA (Device enforcement)

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

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