The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0074-2023·Announced 2022-10-26

Medical Gas Filter Devices Recalled Due to Splitting and Detachment Risk

Teleflex is recalling Iso-Gard Filter S microbial medical gas filters that may split or detach during use. The recall affects 164 units distributed nationwide.

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: The FDA classified this as a Class I recall, which mandates a minimum severity score of 4. Device splitting or detachment during use poses direct risk to the integrity of medical gas delivery systems, though no injuries or illnesses have been reported.

Plain-English summary

Teleflex LLC is recalling certain batches of the Iso-Gard Filter S, a single-use microbial medical gas filter with a tethered cap. The device is used to filter medical gases in clinical settings.

The FDA has classified this as a Class I recall because the device may split or detach during use. This failure could compromise the integrity of the gas delivery system and potentially affect patient safety.

The recall applies to model references 19211T and 19212T with specific lot codes distributed throughout the United States. Healthcare facilities and medical professionals who have received these devices should identify and remove them from service.

If you have received one of these devices, contact Teleflex LLC or your medical device supplier for instructions on replacement and proper handling of the recalled filters.

The recalled product

Product
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
Manufacturer
TELEFLEX LLC
Category
Medical Device — Gas Delivery / Filtration Equipment
Hazard
Affected units
164

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) 19211T
  • UDI: (01)04026704400478(17)250528(10)20FT38
  • (01)04026704400478(17)250628(10)20FT63
  • (01)04026704400478(17)250728(10)20GT03
  • (01)04026704400478(17)250828(10)KMH20H0303
  • (01)04026704400478(17)251028(10)KMH20J0148
  • (01)04026704400478(17)251028(10)KMH20L0135
  • (01)04026704400478(17)251028(10)KMH20L0137
  • (01)04026704400478(17)251128(10)KMH20L0362
  • (01)04026704400478(17)251128(10)KMH20M0236
  • (01)04026704400478(17)251128(10)KMH20M0276
  • (01)04026704400478(17)251228(10)KMH20M0477
  • (01)04026704400478(17)260228(10)KMH21A0397
  • (01)04026704400478(17)260828(10)KMH21C0228
  • (01)04026704400478(17)260928(10)KMH21J0146
  • (01)04026704400478(17)260928(10)KMH21K0122
  • (01)04026704400478(17)260928(10)KMH21K0130
  • (01)04026704400478(17)260928(10)KMH21K0133
  • (01)04026704400478(17)260928(10)KMH21K0137
  • (01)04026704348008(17)241128(10)KMH21K0155

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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