Home / Recalls / TELEFLEX LLC / Z-0076-2023

Z-0076-2023 Class I Ongoing

Recalled by TELEFLEX LLC — Morrisville, NC

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
42 units

Product Description

Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, 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) 19012, UDI: (01)04026704400423(17)250528(10)KMZ21A0099; b) 19012T, UDI: (01)04026704400423(17)250628(10)202025, (01)04026704400423(17)250628(10)202027, (01)04026704400423(17)250828(10)202028, (01)04026704400423(17)250828(10)KMZ20J0079, (01)04026704400423(17)251228(10)KMZ20J0861, (01)04026704400423(17)251228(10)KMZ21A0100, (01)04026704400423(17)251228(10)KMZ21A0127, (01)04026704400423(17)251228(10)KMZ21A0238, (01)04026704400423(17)251228(10)KMZ21A0425, (01)04026704400423(17)251228(10)KMZ21A0427, (01)04026704400423(17)251228(10)KMZ21A0522, (01)04026704400423(17)251228(10)KMZ21A0535, (01)04026704400423(17)251228(10)KMZ21A0617, (01)04026704400423(17)251228(10)KMZ21A0712, (01)04026704400423(17)251228(10)KMZ21A0828, (01)04026704400423(17)251228(10)KMZ21A0854, (01)04026704400423(17)251228(10)KMZ21A0860, (01)04026704400423(17)251228(10)KMZ21A0909, (01)04026704400423(17)260128(10)KMZ21A0926, (01)04026704400423(17)260628(10)KMZ21B0141, (01)04026704400423(17)260628(10)KMZ21G0174, (01)04026704400423(17)260628(10)KMZ21G0180, (01)04026704400423(17)260628(10)KMZ21G0181, (01)04026704400423(17)260728(10)KMZ21G1067, (01)04026704400423(17)260828(10)KMZ21H0277, (01)04026704400423(17)260828(10)KMZ21J0069, (01)04026704400423(17)260928(10)KMZ21J0386, (01)04026704400423(17)260928(10)KMZ21K0208, (01)04026704400423(17)260928(10)KMZ21K0648, (01)04026704400423(17)260928(10)KMZ21K0707, (01)04026704400423(17)261028(10)KMZ21K0856, (01)04026704400423(17)261128(10)KMZ21L0309, (01)04026704400423(17)261128(10)KMZ21M0061, (01)04026704400423(17)261128(10)KMZ21M0492, (01)04026704400423(17)261128(10)KMZ21M0493, (01)04026704400423(17)270128(10)KMZ21M0813, (01)04026704400423(17)270128(10)KMZ22B0105, (01)04026704400423(17)270128(10)KMZ22B0117, (01)04026704400423(17)270128(10)KMZ22B0118, (01)04026704400423(17)270228(10)KMZ22B0508, (01)04026704347995(17)241128(10)KMZ22C0622.

Other recalls by TELEFLEX LLC

  • Z-1882-2023 Class I — Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120800 (May 25, 2023)
  • Z-1867-2023 Class I — Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180060 (May 25, 2023)
  • Z-1927-2023 Class I — Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380035 (May 25, 2023)
  • Z-1861-2023 Class I — Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180030 (May 25, 2023)
  • Z-1874-2023 Class I — Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382030 (May 25, 2023)
  • Z-1834-2023 Class I — Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085 (May 25, 2023)
  • Z-1877-2023 Class I — Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, (May 25, 2023)
  • Z-1865-2023 Class I — Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180050 (May 25, 2023)
  • Z-1945-2023 Class I — Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, (May 25, 2023)
  • Z-1950-2023 Class I — Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, (May 25, 2023)