ClearanceBrief
Recall Z-0377-06 ยท BTG Brush, Biopsy, Bronchoscope (Non-Rigid)

Boston Scientific Corp

Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 90 cm, package of 10 brushes; Catalog No. 1650, Order No M00516501.

DateJan 11, 2006 (initiated Dec 8, 2005)
StatusTerminated
ReasonThe patient sample may become contaminated because the wax plug, intended to protect the sample from contamination during collection, may be missing.
Root causeOther
ActionConsignees were notified via letter dated December 8, 2005.
Quantity12350
DistributionNationwide, 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, Sau
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K780872CYTOLOGY BRUSH
CooperVision, Inc., Sep 7, 1978