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Terminated

PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKIR, Material Number M001PIC402CKIRO. Responsible firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801 USA

FDA Recall Z-1050-05 · Posted 2005-07-28

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLJS
Date Initiated2004-03-05
Date Terminated2006-02-06
Product Quantity45 units

Reason for Recall

Lumens may have incorrect lumen size marked on them.

Firm Action

Letters dated March 5, 2004 with instructions to return product to Boston Scientific.

Root Cause

Other

Distribution Pattern

Nationwide. Medical facilities in CA, GA, IA, IL, ME, MI, MO, NJ, OH, TN TX, UT, WI,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K963097CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)Bmw Medical, Inc. · 1996-10-18

Official Source

View FDA Recall →

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

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