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Terminated

Product in clear plastic pouch labeled: Boston Scientific MEDI-TECH *** VASCULAR DILATOR *** Order No./REF: 48-151 M001481510, 5 Fr. Firm on the label: Boston Scientific Corporation, 480 Pleasant Street, Watertown, MA 02472.

FDA Recall Z-0842-04 · Posted 2004-07-20

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeDRE
Date Initiated2004-03-18
Date Terminated2005-10-25
Product Quantity43 units

Reason for Recall

Product labeled at Vascular Dilator Set 5 Fr contains 5 dilators ranging from 6 Fr to 14 Fr.

Firm Action

Letter dated 4/2/04 flagged as an addendum to a letter dated 3/18/04, with instructions to return product.

Root Cause

Other

Distribution Pattern

Hospitals in CA, CT, FL, GA, IL, MI, NM, OH, WA, WI.

Official Source

View FDA Recall →

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

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