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U.S. Department of Health and Human Services

Class 2 Device Recall Medrad Avanta Multipatient Disposable Sets

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 Class 2 Device Recall Medrad Avanta Multipatient Disposable Setssee related information
Date Initiated by FirmSeptember 20, 2005
Date PostedOctober 21, 2005
Recall Status1 Terminated 3 on January 20, 2006
Recall NumberZ-0083-06
Recall Event ID 33689
510(K)NumberK050456 
Product Classification Set, I.V. Fluid Transfer - Product Code LHI
ProductMedrad Avanta Multi-patient Disposable Sets. Catalog number AVA 500 MPAT
Code Information Lot numbers 50627, 50628, 51069, 51070, 51071, and 51747
Recalling Firm/
Manufacturer
Medrad Inc
1 Medrad Dr
Indianola PA 15051-9759
For Additional Information ContactLaurence R. Kopyta
412-767-2400 Ext. 3621
Manufacturer Reason
for Recall
stress crack on the stopcock
FDA Determined
Cause 2
Other
ActionThe recalling firm issued letters dated 9/20/05 to the hospitals and sales representative informing them of the problem and the need to return the product.
Quantity in Commerce850 units
DistributionThe products were shipped to medical facilities in CA, CO, DE, FL, IL, MA, NC, OH, PA, and VA. The products were also shipped to sales representatives in CA, CO, FL, MA, MN, MO, OK, PA, SC, and WI. The products were sent to the recalling firm''s distributors in the Netherlands, Denmark, France, and Italy.
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.
510(K) Database510(K)s with Product Code = LHI
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