Z-2370-2015Class I

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

Name: Z-2370-2015 HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to...
Creator: Teleflex Medical
Published: 2015-06-01
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2015-06-01 / Terminated

FDA source

Teleflex Medical began a recall of 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... on 2015-06-01. FDA classified it as Class I and gives the reason as "The double swivel connector may crack or separate on the endobronchial tube". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2370-2015
Classification: Class I
Status: Terminated
Initiated: 2015-06-01
Posted: 2015-08-20
Terminated: 2018-04-16
Recalling firm: Teleflex Medical
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.
Product code: CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Reason for recall: The double swivel connector may crack or separate on the endobronchial tube.
FDA root cause: Unknown/Undetermined by firm
Action: Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated June 1, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were directed to contact any customers who had received the product included within the scope of this recall. Customers were directed to immediately discontinue use and quarantine any products with the referenced catalog numbers and lot numbers listed in the notification. Additionally, customers were asked to return any affected product together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 188,195 total units
Distribution: Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2370-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2367-2015	Class I	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19
Z-2368-2015	Class I	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19
Z-2369-2015	Class I	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19
Z-2370-2015	Class I	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19

Product code CBI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)