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 2 Device Recall CooperSurgical

  • 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 CooperSurgical see related information
Date Initiated by Firm November 01, 2005
Date Posted January 18, 2006
Recall Status1 Terminated 3 on May 14, 2012
Recall Number Z-0401-06
Recall Event ID 33940
Product Classification Syringe, Piston - Product Code FMF
Product Milex 60cc Handy-Vak Locking Syringe
Ref: MX500
Code Information Lot number: 39608 Exp. Date April 08
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Drive
Trumbull CT 06611-1350
For Additional Information Contact Maria Perdo
203-601-5200 Ext. 7279
Manufacturer Reason
for Recall		 Potential for the plunger to separate from the piston
FDA Determined
Cause 2		 Other
Action CooperSurgical notified consignees by telephone and follow-up letter dated 11/3/05 via fax. Accounts are requested to discontinue use and return inventory.
Quantity in Commerce 496 units
Distribution CA, CO, HI, IL, MA, NH, PA, VA, WA Foreign: Canada
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.
-
-