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Terminated

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

FDA Recall Z-0419-2016 · Posted 2015-12-15

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeBTT
Date Initiated2014-04-17
Date Terminated2015-12-16
Product Quantity2,600 ea

Reason for Recall

Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed.

Firm 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.

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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