International safety notice

Urgent Field Safety Notice for Iso-Gard® Filter S with Expandi-Flex/Elbow, Tethered Cap; Iso-Gard® Filter S. Iso-Gard® Filter S with Expandi-FlexIso-Gard® Filter S. Tethered Cap; Iso-Gard® Filter S with Expandi-Flex, Tethered Cap; Filter + Catheter Mount by Teleflex (Perak West Malaysia)

Germany / BfArM · DEU · Nov 15, 2022

Key facts

Title Urgent Field Safety Notice for Iso-Gard® Filter S with Expandi-Flex/Elbow, Tethered Cap; Iso-Gard® Filter S. Iso-Gard® Filter S with Expandi-FlexIso-Gard® Filter S. Tethered Cap; Iso-Gard® Filter S with Expandi-Flex, Tethered Cap; Filter + Catheter Mount by Teleflex (Perak West Malaysia)
Regulator Germany / BfArM
Country DEU
Brand Iso-Gard® Filter S with Expandi-Flex/Elbow, Tethered Cap; Iso-Gard® Filter S. Iso-Gard® Filter S with Expandi-FlexIso-Gard® Filter S. Tethered Cap; Iso-Gard® Filter S with Expandi-Flex, Tethered Cap; Filter + Catheter Mount
Manufacturer Teleflex (Perak West Malaysia)
Models KMH21J0328, KMH22A0046, KMH21G0314, KMH20J0037, KMZ21F0534, KMH20K0160, 04026704400485, KMH21F0389, KMZ21L0308, KMZ21E0647, KMH21K0080, KMZ21G0739 and 1795 more
Date Nov 15, 2022
Regulator page bfarm.de

At a glance

  • No Recall
  • No Field safety notice
  • 10–99 Matching device models in FDA data
  • 10–99 Matching catalog numbers in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

Browse all International device safety notices