The Recall Desk
Agency classClass IOur severity: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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Affected units
42

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.

Part of a larger recall action

This product is one of 6 recalled by TELEFLEX LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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