The Recall Desk
HighFDA (Devices)·Z-0105-2022·Announced 2021-10-20

Thoraguard Chest Tube Kit 20 Fr Recalled for Adhesive Joint Failure

Centese Inc. is recalling Thoraguard Chest Tube Kits (20 Fr) because an adhesive joint in the SmartValve component can fail, causing fluid to leak. The affected kits were distributed to a single facility in California.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with potential for serious patient harm during thoracic procedures due to adhesive failure and leakage, though no illnesses or injuries have been reported.

Plain-English summary

Centese Inc. is recalling Thoraguard Chest Tube Kits (20 Fr) with model FGS-1126 and catalog number TGCT120020 due to a defect in the SmartValve component. The adhesive joint in this component can become compromised, resulting in a leak that could compromise the device's function.

This recall affects 310 kits with lot numbers 20100102, 21031703, and 21053102. The affected units were distributed to a single healthcare facility located in California.

Chest tube kits are critical medical devices used in thoracic drainage procedures. A leak in the adhesive joint could impair proper function during clinical use. Healthcare facilities receiving this product should verify their lot numbers against those listed in this recall.

The recalled product

Product
Thoraguard Chest Tube Kit, 20 Fr
Manufacturer
Centese Inc.
Category
Medical Device — Chest Tube Kit
Hazard
  • adhesive-failure
  • leak

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 (3)

  • Model: FGS-1126 Catalog Number: TGCT120020 Lot Numbers 20100102
  • 21031703
  • and 21053102

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category