Recall Z-1300-06 ยท KOG
Boston Scientific Corp
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.
| Date | Jul 27, 2006 (initiated Jun 30, 2006) |
| Status | Terminated |
| Reason | Sterility is compromised because the product is labeled as sterile, but the packages may have holes in them. |
| Root cause | Package design/selection |
| 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. |
| Quantity | 446,097 units |
| 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, Por |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880099 | VAN-TEC BLADDER EVACUATOR Van-Tec, Inc., Mar 2, 1988 |