Z-0376-06

Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 220 cm, package of 10 brushes...

Name: Z-0376-06 Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 220 cm, package of 10 brushes...
Creator: Boston Scientific Corp
Published: 2005-12-08
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-12-08 / Terminated

FDA source

Boston Scientific Corp began a recall of Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 220 cm, package of 10 brushes; Catalog No. 1640, Order No. M00516401 on 2005-12-08. The reason FDA records is "The patient sample may become contaminated because the wax plug, intended to protect the sample from contamination during collection, may be missing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0376-06
Status: Terminated
Initiated: 2005-12-08
Posted: 2006-01-11
Terminated: 2007-03-16
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 220 cm, package of 10 brushes; Catalog No. 1640, Order No. M00516401.
Product code: BTG Brush, Biopsy, Bronchoscope (Non-Rigid)
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.
FDA root cause: Other
Action: Consignees were notified via letter dated December 8, 2005.
Quantity in commerce: 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.
Product codes and lots: Lots 7669915, 7731928, 7809849 and 7580900.

Product code BTG

K780872Class IICytology BrushCooperVision, Inc. / cleared 1978-09-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)