—#38602

Product

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 product code: LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K963097
Affected lot / code info: 919488, 924206

Why it was recalled

Lumens may have incorrect lumen size marked on them.

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Boston Scientific Pl, Natick, Massachusetts 01760-1536

Distribution

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

Timeline

Recall initiated: 2004-03-05
Posted by FDA: 2005-07-28
Terminated: 2006-02-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38602. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.