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Terminated

PICC Custom Kit GENESIS MEDICAL CENTER, 4.5F Dual Lumen , Catalog #60M120522. UPN M00160M1205221. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, 10 Glens Falls Technical Park, Glens Falls, NY

FDA Recall Z-1052-05 · Posted 2005-07-28

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLJS
Date Initiated2004-03-05
Date Terminated2006-02-06
Product Quantity44 kits

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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