Device product

Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use

Z-0073-2023

August 29, 2022

Class I

Product summary

Firm: TELEFLEX LLC
Event: Event 90816
Status: Ongoing
Classification: Class I
Quantity: 7 units
Official record key: device-enforcement:Z-0073-2023

Official wording

Reason: Incidents of device splitting or detaching during use

Code information: 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

Distribution pattern: US nationwide distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Incidents of device splitting or detaching during use