The Recall Desk
HighFDA (Devices)·Z-2370-2015·Announced 2015-08-26

Teleflex Medical Recalls Sheridan Double Swivel Connectors Due to Cracking Risk

Teleflex Medical is recalling Sheridan double swivel connectors because they may crack or separate on endobronchial tubes.

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: The recall involves a medical device with a potential mechanical failure (cracking or separation) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity rating.

Plain-English summary

Teleflex Medical is recalling 188,195 units of HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel connectors. These sterile, prescription-only medical devices are used temporarily to make a flexible tracheal tube rigid to aid its insertion into a patient.

The recall was initiated because the double swivel connector may crack or separate on the endobronchial tube. The affected products were distributed worldwide, including in the United States and in The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand, and Vietnam.

Healthcare providers should stop using the affected lots and contact Teleflex Medical for instructions on how to return the devices. The specific lot numbers affected are listed in the official recall documentation.

The recalled product

Product
HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
Manufacturer
Teleflex Medical
Affected units
188,195

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 (19)

  • Product Code: 5-15401
  • Lot numbers: 01K1300254
  • 01L1300393
  • 01M1300212
  • 01A1400436
  • 01C1400086
  • 73D1400096
  • 73D1400496
  • 73E1400269
  • 73F1400153
  • 73F1400352
  • 73G1400052
  • 73G1400288
  • 73H1400331
  • 73J1400401
  • 73L1400106
  • 73M1400208
  • 73A1500345
  • 73B1500272 and 73C1500255.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Teleflex Medical 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 4 products in this recall →