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Recall Observatory FDA recall evidence

Device 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.

Z-2370-2015

June 01, 2015

Class I

Product summary

Firm
Teleflex Medical
Event
Event 71360
Status
Terminated
Classification
Class I
Quantity
188,195 total units
Official record key
device-enforcement:Z-2370-2015

Official wording

Reason: The double swivel connector may crack or separate on the endobronchial tube.

Code information: 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 pattern: Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The double swivel connector may crack or separate on the endobronchial tube.