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.
This recall has been terminated (originally issued July 27, 2006).
- Company
- Boston Scientific Corp
- Recall Initiated
- June 30, 2006
- Posted
- July 27, 2006
- Terminated
- July 31, 2008
- Recall Number
- Z-1300-06
- Quantity
- 446,097 units
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility is compromised because the product is labeled as sterile, but the packages may have holes in them.
Distribution
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.
Lot / Code Info
All lots expiring on or before June 12, 2010.
Root Cause
Package design/selection
Action Taken
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.