The Recall Desk
HighFDA (Devices)·Z-1855-2022·Announced 2022-10-05

Medline ClearPro Suction Catheter Connector May Separate During Use

Medline ClearPro closed suction catheters may have a connector that separates from the device during patient suctioning. The malfunction affects 65,320 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 confirmed design defect (connector separation) that poses significant risk during critical airway management in ventilator-dependent patients, though no injuries have been reported to date.

Plain-English summary

Medline Industries is recalling MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER devices in sizes 12 Fr, 14 Fr, and 16 Fr. The catheters are supplied in flat peel pouches, with 10 units per inner carton and 20 units per case.

The green connector near the thumb valve can come apart from the device when the catheter is pulled out of the artificial airway during the patient suctioning process. This separation poses a risk of harm in clinical settings where proper suctioning is critical to patient care.

The recall affects 65,320 units distributed nationwide to all 50 U.S. states, the District of Columbia, Puerto Rico, and internationally to Canada, Chile, Colombia, Panama, Qatar, and the United Arab Emirates. Affected lot numbers are identified by their UDI-DI/GTIN codes and lot numbers listed in the FDA recall notice.

Healthcare facilities that have used or have in stock any of the affected lots should discontinue use, quarantine remaining inventory, and contact Medline Industries for guidance on replacement or return.

The recalled product

Product
MEDLINE CLEARPRO 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. ET LENGTH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12; b. ET LENGTH DOUBLE SWIVEL, 14 Fr, Item Number/R
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Airway Management / Respiratory Care
Hazard
  • connector-separation
  • equipment-failure
  • airway-management-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 (20)

  • a. UDI-DI (GTIN) case: (01)20888277703367
  • UDI-DI (GTIN) Each: (01)10888277703360
  • Lot Number 6922040021
  • b. UDI-DI (GTIN) case: (01)20888277703381
  • UDI-DI (GTIN) Each: (01)10888277703384
  • Lot Numbers 6921050011
  • 6921070011
  • 6921070021
  • 6921060011
  • 6921060021
  • 6921080011
  • 6921100011
  • 6921100021
  • 6921120011
  • 6922010011
  • 6922020021
  • 6922030011
  • c. UDI-DI (GTIN) case: (01)20888277703404
  • UDI-DI (GTIN) Each: (01)10888277703407
  • Lot Number 6921120021

Distribution

Distributed nationwide across the United States.

Related recalls

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