Z-0585-2008

Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In...

Name: Z-0585-2008 Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In...
Creator: Lumenis, Inc.
Published: 2007-12-18
License: https://open.fda.gov/license/

Lumenis Ltd / initiated 2007-12-18 / Terminated / root cause: labeling and UDI

FDA source

Lumenis, Inc. began a recall of Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Manufactured By LUMENIS, P.O.Box 240... on 2007-12-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0585-2008
Status: Terminated
Initiated: 2007-12-18
Posted: 2008-04-09
Terminated: 2008-04-09
Recalling firm: Lumenis Ltd
Product: 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.
Product code: GEX Powered Laser Surgical Instrument
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 59 units.
Distribution: MA
Product codes and lots: Lot number 61280807.

Product code GEX

K011703Class IILumenis Versapulse Powersuite Holmium (Ho:yag) and Dual Wavelength (Ho:yag/nd:yag) Surgical Lasers and Delivery DevicesLumenis / cleared 2001-08-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)