16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte… recallZ-0284-06 · Becton Dickinson Medical Systems · initiated Mar 25, 2005

Why it was recalled

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

FDA root cause category: Other

What the company is doing

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

Recall details

Recall number

Z-0284-06

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Mar 25, 2005

Posted by the FDA

Dec 15, 2005

Recalling firm

Becton Dickinson Medical Systems

Quantity

435 units

Product code

LJS

FDA submissions

K920755

Distribution

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.

Product description

16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte Autoguard

Other devices under the same FDA submission

1 device cleared under K920755 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Splittable Needle Introducer 28 GA (1.2F) x 20 mm

  Argon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
  2 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 31670).

• Z-0282-06 · Terminated
  16 G / 5F Dual Lumen L-Cath catheter only.
• Z-0283-06 · Terminated
  16 G / 5F Dual Lumen L-Cath Basic Kit with Insyte Autoguard
• Z-0285-06 · Terminated
  16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte
• Z-0286-06 · Terminated
  16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte
• Z-0287-06 · Terminated
  16 G / 5F Dual Lumen L-Cath Basic Kit with U-Wing
• Z-0288-06 · Terminated
  16 G / 5F Dual Lumen L-Cath complete kit with U-Wing