Teleflex Medical: Medical Device Recall in 2015 - (Recall #: Z-2370-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.
Product Description:

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.

Product Classification:

Class I

Date Initiated: June 1, 2015
Date Posted: August 26, 2015
Recall Number: Z-2370-2015
Event ID: 71360
Reason for Recall:

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

Status: Terminated
Product Quantity: 188,195 total units
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.

Voluntary or Mandated:

Voluntary: Firm initiated