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Terminated

16 G / 5F Dual Lumen L-Cath complete kit with U-Wing

FDA Recall Z-0288-06 · Posted 2005-12-15

Recalling FirmBecton Dickinson Medical Systems
Recall StatusTerminated
Product CodeLJS
Date Initiated2005-03-25
Date Terminated2011-08-08
Product Quantity220 units

Reason for Recall

Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.

Firm Action

Consignees were notified via telephone and fax letter, beginning 04/25/2005.

Root Cause

Other

Distribution Pattern

AL, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NJ, OH, OK, PA, TN, TX, WA. No Government or military consignees. Foreign distribution to Australia, Canada, Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K920755L-CATH PEEL AWAY SYSTEM CATHETERLuther Medical Products, Inc. · 1993-06-07

Official Source

View FDA Recall →

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

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