Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 90 cm, package of 10 brushes; Catalog No. 1650
FDA device recall Z-0377-06 · posted 2006-01-11 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- The patient sample may become contaminated because the wax plug, intended to protect the sample from contamination during collection, may be missing.
- Action taken
- Consignees were notified via letter dated December 8, 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTG
- Quantity affected
- 12350
- Distribution
- Nationwide, Aruba, Australia, Belize, Bolivia, Bulgaria, Chile, China, Dominican Republic, Ecuador, Guatemala, Haiti, Honduras, Hong Kong, India, Indonesia, Israel, Jamaica, Jordan, Korea, Kuwait, Leb
- Date initiated
- 2005-12-08
- Date posted
- 2006-01-11
- Date terminated
- 2007-03-16
- 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 |
|---|---|---|
| CYTOLOGY BRUSH (K780872) | CooperVision, Inc. | 1978-09-07 |