FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 220 cm, package of 10 brushes; Catalog No. 1640, Order No. M00516401.
- Recall number
- Z-0376-06
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 220 cm, package of 10 brushes; Catalog No. 1640, Order No. M00516401.
- Status
- Terminated
- Initiated
- 2005-12-08
- Posted
- 2006-01-11
- Terminated
- 2007-03-16
- Reason
- The patient sample may become contaminated because the wax plug, intended to protect the sample from contamination during collection, may be missing.
- Root cause
- Other
- Action
- Consignees were notified via letter dated December 8, 2005.
- Quantity
- 600
- Distribution
- Nationwide, Aruba, Australia, Belize, Bolivia, Bulgaria, Chile, China, Dominican Republic, Ecuador, Guatemala, Haiti, Honduras, Hong Kong, India, Indonesia, Israel, Jamaica, Jordan, Korea, Kuwait, Lebanon, Malaysia, Moldavia, New Zealand, Nicaragua, Oman, Pakistan, Panama, Paraguay, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Trinidad, Tobago, and Venezuela.
- Lot, serial or model codes
- Lots 7669915, 7731928, 7809849 and 7580900.
- 510(k) numbers
- ["K780872"]
- PMA numbers
- not on file
- Product code
- BTG
- Firm FEI
- 1828132
- Firm city
- Spencer
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28