Home / Recalls / TELEFLEX LLC / Z-0073-2023

Z-0073-2023 Class I Ongoing

Recalled by TELEFLEX LLC — Morrisville, NC

FDA device recall Z-0073-2023 was initiated by TELEFLEX LLC on Aug 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: Oct 26, 2022
Initiation Date: Aug 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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0073-2023
openFDA file date: Oct 6, 2026
Loaded by RegDataLab: Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.

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