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U.S. Department of Health and Human Services

Class 2 Device Recall Urovac

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 Class 2 Device Recall Urovacsee related information
Date Initiated by FirmJune 30, 2006
Date PostedJuly 27, 2006
Recall Status1 Terminated 3 on July 31, 2008
Recall NumberZ-1300-06
Recall Event ID 35748
510(K)NumberK880099 
Product Classification unknown device name - Product Code KOG
ProductBoston Scientific Urovac Bladder Evacuator, sterile, single use only; REF/Catalog no. 730-125 and sold individually as UPN M0067301250 and in packaged of ten as UPN M0067301251.
Code Information All lots expiring on or before June 12, 2010.
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information ContactCindy Finney
508-683-4678
Manufacturer Reason
for Recall		Sterility is compromised because the product is labeled as sterile, but the packages may have holes in them.
FDA Determined
Cause 2		Package design/selection
ActionU.S. accounts were notified via recall letter dated 6/30/06 to cease use of the product and to return it to the firm. International accounts were also notified.
Quantity in Commerce446,097 units
DistributionNationwide and worldwide, including Argentina, Bangladesh, Belgium, Canada, Chile, China, Colombia, Dominican Republic, Egypt, El Salvador, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Portugal, Romania, South Africa, Spain, Sri Lanka, Sweden, Tunisia, Turkey and Venezuela.
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 = KOG
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