Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 220 cm, package of 10 brushes; Catalog No. 1640, Order No. M00516401.
FDA Recall Z-0376-06 · Posted 2006-01-11
Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeBTG
Date Initiated2005-12-08
Date Terminated2007-03-16
Product Quantity600
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.
Firm Action
Consignees were notified via letter dated December 8, 2005.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.