FDA Device

7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton.

Hazard

Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR).

What You Should Do

Remedy

The recalling firm telephoned their customers on 91/05 & 9/14/05 to inform them of the problem.

Affected by this recall?

Get a free legal consultation about this recall.

Talk to a Lawyer →

Affiliate link

Products

7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton.
Brand
B. Braun Medical, Inc.
UPC
Lot numbers 60710907 and 60710908

Units Affected

8000 units

Related Recalls

FDA DEVICE

Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75

 FDA DEVICE

Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654225.

 FDA DEVICE

Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2)

 FDA DEVICE

Scanlan Premier Jacobson Micro Scissors, spring style, flat handle, V-neck, 125-degree angled micro fine blades, 6-1/4'', 16 cm. Catalog Number 7007-449.

 FDA DEVICE

Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432-5604.