Z-0419-2016Class II

Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit...

Name: Z-0419-2016 Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit...
Creator: Teleflex Medical
Published: 2014-04-17
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-04-17 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column on 2014-04-17. FDA classified it as Class II and gives the reason as "Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed". 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-0419-2016
Classification: Class II
Status: Terminated
Initiated: 2014-04-17
Posted: 2015-12-15
Terminated: 2015-12-16
Recalling firm: Teleflex Medical
Product: Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Reason for recall: Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Teleflex sent an "Urgent Medical Device Recall Notification" dated April 17, 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 voluntary 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: 2,600 ea
Distribution: US Distribution to the states of : AL, AZ, CA, GA, IL, KY, LA, MA, MI, MN, NJ, NY, NC, OH, OK, OR, PA, TN, TX and WA.
Product codes and lots: Lot Numbers : 02K1300128 and 02L1302324

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0419-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0419-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-15

Product code BTT

K031383Class IIModel 780Hudson Respiratory Care, Inc. / cleared 2003-07-07

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)