Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.
FDA Recall Z-1403-2018 · Posted 2018-04-17
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Recalling FirmTeleflex Medical Europe Ltd
Recall StatusTerminated
Product CodeBZA
Date Initiated2018-03-27
Date Terminated2021-05-04
Product Quantity103910 units
Reason for Recall
These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient.
Firm Action
Teleflex initiated the recall by letter on 03/27/2018. The firm directed the consignee as follows:
"1. If you have affected stock, immediately discontinue use and quarantine any products with the product code and lot numbers listed above.
2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. 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 products to Teleflex Medical.
3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document your receipt of this letter."
Root Cause
Device Design
Distribution Pattern
US Nationwide in the states of AU, CA, NZ
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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