Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236, Ref. # M001452360. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
FDA Recall Z-0781-05 · Posted 2005-04-28
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLLD
Date Initiated2005-02-25
Date Terminated2006-08-09
Product Quantity214 units
Reason for Recall
Potential separation of the port base from the port cover after implantation.
Firm Action
Letters sent 3/11/2005 via Federal Express to hospitals receiving affected product. Customers instructed to remove/return product, notify physicians, evaluate patients and explant devices whenever possible.
Root Cause
Other
Distribution Pattern
1215 units shipped to 123 hospitals throughout the U.S. 2 units shipped to Boston Scientific in South Africa where 1 unit had been used as a demo (non-human use) and 1 units is in BSC control
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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