• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Boston Scientificsee related information
Date Initiated by FirmAugust 28, 2007
Date PostedOctober 31, 2007
Recall Status1 Terminated 3 on July 10, 2008
Recall NumberZ-0116-2008
Recall Event ID 44736
Product Classification Biopsy Forceps - Product Code FFF
ProductBoston Scientific Radial Jaw Large Capacity Biopsy Forceps, Sterile, 240 mm. Box of 20 U PN Number: M00513321 REF: 1332-20
Code Information Lot Number: 8990184
Recalling Firm/
Manufacturer
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact
508-650-8798
Manufacturer Reason
for Recall
Device lacked manufacturing finishing process resulting in endoscope damage.
FDA Determined
Cause 2
Process control
ActionBoston Scientific notified accounts by letter on 8/28/07 by Federal Express Priority mail. Accounts are requested to remove product from inventory and return product.
Quantity in Commerce145 boxes
DistributionWorldwide, including USA, Sweden, and South Africa.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-