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Terminated

Adapter for ACMI Hysteroscope Catalog Number: 55035

FDA Recall Z-1020-05 · Posted 2005-07-19

Recalling FirmBoston Scientific Marlbourgh
Recall StatusTerminated
Product CodeMNB
Date Initiated2005-07-28
Date Terminated2006-06-14

Reason for Recall

The Hysteroscope Adapter used with the HTA System may disassemble and result in a fluid leak.

Firm Action

Boston Scientifc notified accounts by letter dated June 28, 2005 via Federal Express. Accounts are requested to check invnetory and return. Any adapters out of box have no lot identification and can be tested per instructions

Root Cause

Other

Distribution Pattern

CA, DE, FL, MA, MO, MS, OH, NE, NY, PA, UT, WI

Official Source

View FDA Recall →

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

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