The Recall Desk
HighFDA (Devices)·Z-1857-2022·Announced 2022-10-05

Medline ClearPro Trach T-Piece Suction Catheter May Separate at Connector

Medline is recalling 136,080 ClearPro Trach T-Piece Closed Suction Catheters because the suction catheter can come apart from the connector during patient suctioning.

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: This is an FDA Class II recall for a medical device with potential for harm (connector separation during patient care) but no reported injuries or illnesses. Per the severity rubric, risk-of-harm products without reported injury are classified as High.

Plain-English summary

Medline Industries, LP is recalling 136,080 units of the MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER in 14 French size, including variants labeled as DYNCPTP14 and DYNCPTP14T. These closed suction catheters are supplied as flat peel pouches with 10 units per inner carton.

The suction catheter can come apart from the green connector near the thumb valve during the patient suctioning process when the catheter is pulled out of the artificial airway. This separation could compromise suctioning function during critical airway management.

The affected devices were distributed nationwide throughout the United States and Puerto Rico, and internationally to Canada, Chile, Colombia, Panama, Qatar, and the United Arab Emirates. Hospitals, clinics, and other healthcare facilities that use these catheters may have affected inventory.

Healthcare providers with affected catheters should contact Medline Industries for return and replacement instructions. Specific lot numbers include 6922030011 (variant a) and for variant b: 6921050011, 6921060011, 6921040012, 6921110011, 6921120011, 6921120012, 6922010011, 6922010012, 6922010031, 6922020031, and 6922030011. Additional information is available on the FDA recall website.

The recalled product

Product
MEDLINE CLEARPRO TRACH T-PIECE 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 T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14; b. TRACH T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14T
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Respiratory / Airway Management
Hazard
  • connector-separation
  • device-failure

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 (15)

  • a. UDI-DI (GTIN) case: (01)20888277703466
  • UDI-DI (GTIN) Each: (01)10888277703469
  • Lot Numbers 6922030011
  • b. UDI-DI (GTIN) case: (01)20888277703473
  • UDI-DI (GTIN) Each: (01)10888277703476
  • Lot Numbers 6921050011
  • 6921060011
  • 6921040012
  • 6921110011
  • 6921120011 6921120012
  • 6922010011
  • 6922010012
  • 6922010031
  • 6922020031
  • 6922030011.

Distribution

Distributed nationwide across the United States.

Related recalls

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