Boston Scientific Urovac Bladder Evacuator, sterile, single use only; REF/Catalog no. 730-125 and sold individually as U
FDA device recall Z-1300-06 · posted 2006-07-27 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Sterility is compromised because the product is labeled as sterile, but the packages may have holes in them.
- 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.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- KOG
- Quantity affected
- 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,
- Date initiated
- 2006-06-30
- Date posted
- 2006-07-27
- Date terminated
- 2008-07-31
- Location
- Spencer, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VAN-TEC BLADDER EVACUATOR (K880099) | Van-Tec, Inc. | 1988-03-02 |