Z-0073-2023 Class I Ongoing
FDA device recall Z-0073-2023 was initiated by TELEFLEX LLC on August 29, 2022 and is designated Class I. Reason for recall: Incidents of device splitting or detaching during use The recall status is ongoing. Affected quantity: 7 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 26, 2022
- Initiation Date
- August 29, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
Product Description
Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
Reason for Recall
Incidents of device splitting or detaching during use
Distribution Pattern
US nationwide distribution
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