Boston 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.
FDA Recall Z-1300-06 · Posted 2006-07-27
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Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeKOG
Date Initiated2006-06-30
Date Terminated2008-07-31
Product Quantity446,097 units
Reason for Recall
Sterility is compromised because the product is labeled as sterile, but the packages may have holes in them.
Firm Action
U.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.
Root Cause
Package design/selection
Distribution Pattern
Nationwide 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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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