Teleflex Medical: Medical Device Recall in 2015 - (Recall #: Z-2368-2015)

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-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.

Product Classification:

Class I

Date Initiated: June 1, 2015

Date Posted: August 26, 2015

Recall Number: Z-2368-2015

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: 5-16128, Lot numbers: 73L1400012, 73K1400582, 73L1400233 and 73A1500039; Product Code: 5-16135, Lot numbers: 73B1500259, 73B1500293, 73C1500401, 73C1500426, 01K1300470, 01B1400479, 73D1400498, 73F1400096, 73H1400443, 73J1400117, 73K1400583, 73L1400094, 73A1500205, 73A1500206 and 73B1500258; Product Code: 5-16137, Lot numbers: 73B1500354, 73B1500355, 73C1500402 and 73C1500427; Product Code: 5-16139, Lot numbers: 73G1400177, 73H1400444, 73L1400095, 73A1500041 and 73A1500203; Product Code: 5-16141, Lot numbers: 01L1300156, 01A1400452, 73G1400178, 73G1400510, 73H1400009, 73K1400553 and 73B1500257.

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