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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Lumenis, Inc.
Lot Codes / Batch Numbers
Lot number 61280807.
Products Sold
Lot number 61280807.
Lumenis, Inc. is recalling Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, M due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MA
Page updated: Jan 10, 2026