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Terminated

Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2.7 mm), sterile, single use only, model M001481541; Catalog No. 48-154.

FDA Recall Z-1104-04 · Posted 2004-07-20

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeDRE
Date Initiated2004-06-16
Date Terminated2005-02-11
Product Quantity1840

Reason for Recall

Labeling mix-up as to product size; 8FR may be labeled 10FR and vice versa.

Firm Action

Recall letters dated June 16, 2004 were sent to consignees requesting product return.

Root Cause

Other

Distribution Pattern

Nationwide and Netherlands.

Official Source

View FDA Recall →

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

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