The Recall Desk
HighFDA (Devices)·Z-1856-2022·Announced 2022-10-05

Medline suction catheters recalled due to connector separation risk

Medline ClearPro Trach Double Swivel Closed Suction Catheters may have the green connector separate from the device during patient suctioning. The recall affects 34,920 units distributed nationwide and internationally.

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 medical device with a mechanical failure hazard that could impair device function during critical airway suctioning. No reported injuries or illnesses in the source, consistent with the rubric criterion for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling 34,920 units of the ClearPro Trach Double Swivel Closed Suction Catheter due to a connector separation hazard. The green connector near the thumb valve can come apart from the main device during patient suctioning, specifically when withdrawing the catheter from an artificial airway.

The recall affects TRACH DOUBLE SWIVEL models in 12 Fr and 14 Fr sizes, with specific lot numbers included in the recall notice. Affected devices were distributed nationwide to all U.S. states and Puerto Rico, as well as internationally to Canada, Chile, Colombia, Panama, Qatar, and the United Arab Emirates.

Healthcare facilities and providers using these devices should verify their inventory against the recalled lot numbers. For information about replacement supplies or additional details, contact Medline Industries or the FDA.

The recalled product

Product
MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12T b. TRACH DOUBLE SWIVEL, 14 Fr, Item Number/REF:
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Respiratory / Airway Suctioning
Hazard
  • connector-separation
  • device-malfunction
  • airway-obstruction-risk

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 (13)

  • a. UDI-DI (GTIN) case: (01)20888277703374
  • UDI-DI (GTIN) Each: (01)10888277703377
  • Lot Numbers 6921090011
  • 6922030011
  • b. UDI-DI (GTIN) case: (01)20888277703398
  • UDI-DI (GTIN) Each: (01)10888277703391
  • Lot Numbers 6921040012
  • 6921070011
  • 6921080011
  • 6921100011
  • 6921120011
  • 6921120021
  • 6922040011

Distribution

Distributed nationwide across the United States.

Related recalls

Same category