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Terminated

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

FDA Recall Z-0377-06 · Posted 2006-01-11

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeBTG
Date Initiated2005-12-08
Date Terminated2007-03-16
Product Quantity12350

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.

K780872CYTOLOGY BRUSHCooperVision, Inc. · 1978-09-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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