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U.S. Department of Health and Human Services

Class 2 Device Recall CooperSurgical

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 Class 2 Device Recall CooperSurgicalsee related information
Date Initiated by FirmNovember 01, 2005
Date PostedJanuary 18, 2006
Recall Status1 Terminated 3 on May 14, 2012
Recall NumberZ-0401-06
Recall Event ID 33940
Product Classification Syringe, Piston - Product Code FMF
ProductMilex 60cc Handy-Vak Locking Syringe Ref: MX500
Code Information Lot number: 39608 Exp. Date April 08
FEI Number 1216677
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Drive
Trumbull CT 06611-1350
For Additional Information ContactMaria Perdo
203-601-5200 Ext. 7279
Manufacturer Reason
for Recall		Potential for the plunger to separate from the piston
FDA Determined
Cause 2		Other
ActionCooperSurgical 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 Commerce496 units
DistributionCA, CO, HI, IL, MA, NH, PA, VA, WA Foreign: Canada
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.
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