Recall Z-0652-2010 ยท BZA Connector, Airway (Extension)
Telefelx Medical
Hudson RCI One Way Valve, 22mm E.D. to 22mm O.D., REF 1665, Rx Only, Teleflex Medical, Research Triangle park, NC 27709
| Date | Jan 15, 2010 (initiated Dec 2, 2009) |
| Status | Terminated |
| Reason | Products 1664 and 1665 are each one-way valves that offer low flow resistance, each in one, opposite direction. Each of these valves demonstrate the appropriate direction with a red arrow. The reason for this recall is incorrect packaging; product code 1664 was incorrectly packaged as product code 1665. If the red arrows are not followed, the valve may be placed in the circuit in the wrong |
| Root cause | Packaging |
| Action | Consignees were notified by letter via next day delivery. Each consignee was sent a letter requesting acknowledgement of the recall and a request to return all of the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second maili |
| Quantity | 2450 eaches |
| Distribution | CA, IL, NE, NJ, TX, VA, WI and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.