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Terminated

Groshong NXT 5 Fr. Dual-Lumen Reverse Taper PICC

FDA Recall Z-0544-06 · Posted 2006-03-16

Recalling FirmBard Access Systems, Inc
Recall StatusTerminated
Product CodeLJS
Date Initiated2005-12-20
Date Terminated2009-08-11
Product Quantity743 units

Reason for Recall

Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions.

Firm Action

Consignees were notified by letter on 12/20/2005.

Root Cause

Other

Distribution Pattern

Nationwide, including VA facilities in CA, FL and IL. No foreign or military distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K034020GROSHONG NXT PICC CATHETERSC.R. Bard, Inc. · 2004-01-21K023374GROSHONG NXT DUAL LUMEN PICC CATHETERSC.R. Bard, Inc. · 2002-12-18

Official Source

View FDA Recall →

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

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