PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous Catheter is a packaged configuration comprised of a silicone Central Venous Catheter with PASV Valve, Guidewire, Syringe, Needle, Tunneler, Scalpel, Sheath/Dilator, and caps. Firm on the label: Boston Scientific*** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
FDA Recall Z-1112-05 · Posted 2005-08-10
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLJS
Date Initiated2004-05-25
Date Terminated2006-02-06
Product Quantity290
Reason for Recall
Kits labeled to contain 0.028" guidewire contain 0.038" guidewire.
Firm Action
Letters dated May 25, 2004 with instructions to return product to the Quincy, MA location.
Root Cause
Other
Distribution Pattern
278 units shipped to 31 consignees throughout the U.S. 12 units shipped to one foreign consignees located in the UK.
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.