Z-2108-2014Class II

Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient...

Name: Z-2108-2014 Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient...
Creator: Teleflex Medical
Published: 2014-07-09
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-07-09 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is... on 2014-07-09. FDA classified it as Class II and gives the reason as "The temperature probe does not properly connect to the temperature port". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2108-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-09
Posted: 2014-07-23
Terminated: 2017-03-09
Recalling firm: Teleflex Medical
Product: Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier.
Product code: CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Reason for recall: The temperature probe does not properly connect to the temperature port.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Teleflex Medical sent an Urgent Medical Device Recall Notification dated July 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you have received products that are subject to this recall. We are now notifying our customers to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-866- 804-9881, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 11,679 units
Distribution: Worldwide Distribution - US including the states of CA, FL, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, PA, TN, TX and VA, and the countries of Argentina, Chile, Colombia, and the Philippines
Product codes and lots: Catalog Number: 1696, Lot numbers: 02K1301986, 02L1300010, 02L1300037, 02L1301081, 02L1301783, 02M1300190, 02M1300236, 02A1400518 02A1401286, 02A1402358, 02B1400178, 02B1400715 & 02B1401320.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2108-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2107-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-23
Z-2108-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-23

Product code CAI

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)