FDA · Medical device recall

16 G / 5F Dual Lumen L-Cath catheter only and 6 more products

Dec. 15, 2005

Date posted by the FDA: Dec. 15, 2005
Status: Terminated
Filed by: Becton Dickinson Medical Systems
Reason: Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
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.

7 products in this recall

16 G / 5F Dual Lumen L-Cath catheter only

Product: 16 G / 5F Dual Lumen L-Cath catheter only.
Quantity: 8090 units
Codes and lots: REF 384468. All lots manufactured since 1999 to 3/7/2005.
Recall started: March 25, 2005
Device type: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Root cause (FDA): Other
What the company told customers: Consignees were notified via telephone and fax letter, beginning 04/25/2005.
Recall number: Z-0282-06

16 G / 5F Dual Lumen L-Cath Basic Kit with Insyte Autoguard

Product: 16 G / 5F Dual Lumen L-Cath Basic Kit with Insyte Autoguard
Quantity: 715 units
Codes and lots: REF 384584
Recall started: March 25, 2005
Device type: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Root cause (FDA): Other
What the company told customers: Consignees were notified via telephone and fax letter, beginning 04/25/2005.
Recall number: Z-0283-06

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

Product: 16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte Autoguard
Quantity: 435 units
Codes and lots: REF 384590
Recall started: March 25, 2005
Device type: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Root cause (FDA): Other
What the company told customers: Consignees were notified via telephone and fax letter, beginning 04/25/2005.
Recall number: Z-0284-06

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

Product: 16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte
Quantity: 5740 units
Codes and lots: REF 384426
Recall started: March 25, 2005
Device type: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Root cause (FDA): Other
What the company told customers: Consignees were notified via telephone and fax letter, beginning 04/25/2005.
Recall number: Z-0285-06

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

Product: 16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte
Quantity: 3750 units
Codes and lots: REF 384427
Recall started: March 25, 2005
Device type: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Root cause (FDA): Other
What the company told customers: Consignees were notified via telephone and fax letter, beginning 04/25/2005.
Recall number: Z-0286-06

16 G / 5F Dual Lumen L-Cath Basic Kit with U-Wing

Product: 16 G / 5F Dual Lumen L-Cath Basic Kit with U-Wing
Quantity: 14,270 units
Codes and lots: REF 384424
Recall started: March 25, 2005
Device type: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Root cause (FDA): Other
What the company told customers: Consignees were notified via telephone and fax letter, beginning 04/25/2005.
Recall number: Z-0287-06

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

Product: 16 G / 5F Dual Lumen L-Cath complete kit with U-Wing
Quantity: 220 units
Codes and lots: REF 384425
Recall started: March 25, 2005
Device type: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Root cause (FDA): Other
What the company told customers: Consignees were notified via telephone and fax letter, beginning 04/25/2005.
Recall number: Z-0288-06

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0282-06, Z-0283-06, Z-0284-06, Z-0285-06, Z-0286-06, Z-0287-06, Z-0288-06. The agency record governs; check it and the company before acting.

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