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U.S. Department of Health and Human Services

Class 2 Device Recall Medrad Avanta MultiPatient Disposable Hand Controller

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 Class 2 Device Recall Medrad Avanta MultiPatient Disposable Hand Controllersee related information
Date Initiated by FirmOctober 25, 2007
Date PostedDecember 11, 2007
Recall Status1 Terminated 3 on April 22, 2008
Recall NumberZ-0292-2008
Recall Event ID 45817
Product Classification Angiographic Injector and Syringe. - Product Code DXT
ProductMedrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog number AVA 500 HC, For Use with MEDRAD Avant Fluid Management System, MEDRAD, Inc., Indianola, PA 15051
Code Information Catalog Number : AVA500HC. Lot Numbers: 0906AACL01, 0906AACL02, 1006AACL01, 1006AACL02, 1006AACL03, 1106AACL01, 1106AACL03, 1106AACL04, 1106AACL05, 1206AACL01, 1206AACL02, 1206AACL03, 0107AACL01, 0107AACL02, 0107AACL03, 0107AACL04, 0107AACL05, 0107AACL06, 0207AACL01, 0307AACL01, 0307AACL02, 0307AACL03, 0407AACL01, 0407AACL02, 0507AACL01, 0507AACL02, 0607AACL01, 0607AACL02, 0607AACL03, and 0707AACL01.
Recalling Firm/
Manufacturer		 Medrad Inc
1 Medrad Dr
Indianola PA 15051-9759
For Additional Information ContactKimberly Platt
724-940-7967
Manufacturer Reason
for Recall		Sterility (package integrity) compromised: Incomplete package seal; sterility may be compromised
FDA Determined
Cause 2		Packaging process control
ActionThe recalling firm issued an Urgent Medical Device Field Correction Letter dated 10/25/07 via Federal Express to their customers informing them of the problem. Customers can either return the product or consistent with the indicated use and established pratice of sheathing, utilize sterile sheaths with the hand controllers for up to five patients. Each letter is being accompanied by a box of 25 sheaths.
Quantity in Commerce25, 977 units
DistributionWorldwide-USA and countries of Germany, Israel, Finalnd, Italy, Netherland, Austria, France, Japan, Denmark, Ireland, South Africia, Australia, Saudi Arabia, Singapore, Canada, New Zealand, Spain, Sweden, Portugal, Korea, Great Britain, Turkey and The United Arab Emerites.
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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