Recall Z-0146-04 ยท DXT Injector And Syringe, Angiographic
Kyphon Inc
KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A. Kyphon Catalog Number: A08A. The medical device is distributed by Kyphon under the brand name KyphX Xpander Inflation Syringe. This medical device is provided as an individual stand-alone package (which also contains an accessory locking syringe device) and as an individually packaged component of the KyphoPak Tray.
| Date | Jul 20, 2004 (initiated Oct 13, 2003) |
| Status | Terminated |
| Reason | Devices for which sterility may be compromised as evidenced by a loss of package integrity. |
| Root cause | Other |
| Action | On October 13, 2003, all consignees were notified via letter and on-site visit by a Kyphon sales representative, informing them of the affected devices and providing instructions on the recall. |
| Quantity | 211 syringes |
| Distribution | There were a total of 188 direct customers that received the recalled product distributed by Kyphon. There were 0 (zero) wholesaler dealers, distributors, retailers that received the recalled product distributed by Kyphon. The recalled product was distributed in the United States only. Recalled pr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011811 | MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE Merit Medical Systems, Inc., Aug 22, 2001 |