Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall

  • 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 3 Device Recall see related information
Date Initiated by Firm August 09, 2004
Date Posted September 14, 2004
Recall Status1 Terminated 3 on October 26, 2005
Recall Number Z-1443-04
Recall Event ID 29795
510(K)Number K813462  
Product Classification Instrument, Biopsy - Product Code KNW
Product Manual Biopsy Devices containing AIM system: Chiba Needle, 8 inch/20 cm, 22 gauge, Cat. #40-103, Material #M001401031 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street, Watertown, MA 02472.
Code Information 6503081, 6507526
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Marie Peters
508-652-5875
Manufacturer Reason
for Recall		 Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.
FDA Determined
Cause 2		 Other
Action Letters dated 8/9/04 hand delivered by Boston Scientific Sales Representatives. Sales Reps will visit each consignee and assist customers in locating affected units and will place a sticker label on each unit.
Quantity in Commerce 48 cartons x 10 units
Distribution Products sold to 53 medical facilities nationwide and one consignee in Italy.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = KNW and Original Applicant = OCEAN MEDICAL PRODUCTS, LTD.
-
-