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Terminated

VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (5 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-994. Firm on the label: Boston Scientific.

FDA Recall Z-0760-04 · Posted 2004-07-20

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDRE
Date Initiated2004-03-05
Date Terminated2005-10-26
Product Quantity100 units (box/10)

Reason for Recall

Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr.

Firm Action

Letter dated 3/5/04 with instructions to return product.

Root Cause

Other

Distribution Pattern

42 domestic hospitals nationwide and one distributor in Canada.

Official Source

View FDA Recall →

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

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