Recall Z-1403-2018 ยท BZA Connector, Airway (Extension)
Teleflex Medical Europe Ltd
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.
| Date | Apr 17, 2018 (initiated Mar 27, 2018) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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 recalls@teleflex.com. 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 inst |
| Quantity | 103910 units |
| Distribution | US Nationwide in the states of AU, CA, NZ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.