The Recall Desk
SevereFDA (Devices)·Z-0076-2023·Announced 2022-10-26

Medical gas filter recalled due to splitting and detachment risk

TELEFLEX LLC is recalling Iso-Gard Filter S medical gas filters due to incidents of device splitting or detaching during use. The affected filters may compromise patient safety.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I medical device recall, which requires a minimum severity score of 4. Device splitting or detachment during use of a medical gas filter poses a direct risk to patient safety, though no specific injuries or deaths are documented in the source material.

Plain-English summary

TELEFLEX LLC is recalling Iso-Gard Filter S with Expandi-Flex/Elbow microbial medical gas filters. The recalled products are Model REF 19012 (OUS only) and Model REF 19012T with Tethered Cap (OUS only). These are single-use medical gas filters with nationwide US distribution. A total of 42 units are affected.

The recall is due to incidents of device splitting or detaching during use. If a filter splits or detaches during medical gas delivery, it could compromise the integrity of the system and potentially harm the patient.

Healthcare providers and users of these filters should stop using the affected units immediately and contact TELEFLEX LLC with the specific UDI (Unique Device Identifier) codes found on the product packaging to determine if their units are affected and to arrange for returns and replacement filters.

The recalled product

Product
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
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory / Medical Gas
Hazard
  • device-splitting
  • device-detachment

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

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