Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Manuf
FDA device recall Z-0585-2008 · posted 2008-04-09 · Terminated
Recall details
- Recalling firm
- Lumenis, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 59 units.
- Distribution
- MA
- Date initiated
- 2007-12-18
- Date posted
- 2008-04-09
- Date terminated
- 2008-04-09
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES (K011703) | Lumenis | 2001-08-29 |