RecallRadar

FDA Device recall Z-2370-2015

HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile

On 2015-08-26 the FDA classified a Class I recall of HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile by Teleflex Medical, citing the double swivel connector may crack or separate on the endobronchial tube.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2370-2015
ClassificationClass I
Statusterminated
Initiated2015-06-01
Published2015-08-26
Last updated2026-09-13 11:53 UTC
CompanyTeleflex Medical
DistributionUS

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.

Reason

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

Identifiers

code_info
Product Code: 5-15401, Lot numbers: 01K1300254, 01L1300393, 01M1300212, 01A1400436, 01C1400086, 73D1400096, 73D1400496,…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2370-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.