Recall Z-0585-2008 ยท GEX Powered Laser Surgical Instrument
Lumenis, Inc.
Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Manufactured By LUMENIS, P.O.Box 240, Yokneam, ISRAEL.
| Date | Apr 9, 2008 (initiated Dec 18, 2007) |
| Status | Terminated |
| Reason | Incorrect Label: The Units outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed to the product indicated that it is a 365 micron fiber. The micron fiber contained in the inner pouch is 200 micro fiber. The inner product is mislabeled with the wrong size. |
| Root cause | Labeling mix-ups |
| Action | The firm notified Consignee by certified letter on 12/18/2007, and asked that all affected products be return. Any questions concerning this recall can be addressed by contacting the Manager, Regulatory Compliance, at 1-877-586-3646 ext. 3355. |
| Quantity | 59 units. |
| Distribution | MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011703 | LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES Lumenis, Aug 29, 2001 |