FDAFDA · Food and drugs·Recall number Z-0536-2015

An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Medline Industries, Medsaver M S I Precision, and Surgical Direct brand names.

Published December 17, 2014 · Recall initiated: September 8, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Instrumed International, Inc.
Distributor: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Lot: 1) Instrumed Product Name: Valvulotome 6 1/4" Retrograde; Instrumed Product Number: 500-05626; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome 6 1/4" Retrograde; Symmetry Surgical Item Number: 55-8685; Lot Numbers: 030412, 060413, 070513. 2) Instrumed Product Name: Valvulotome 6 1/4" Retrograde; Instrumed Product Number: 500-05626; Trade Name: CareFusion; CareFusion Product Name: Valvulotome 6 1/4" Retrograde; CareFusion Item Number: 55-8685; Lot Number: 070513. 3) Instrumed Product Name: Valvulotome 6 1/4" Retrograde; Instrumed Product Number: 500-05626; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, retro, 6 1/4"; Boss Instruments Item Number: 65-7048; Lot Numbers: 030412, 060413, 070513, 110411. 4) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Valvulotome, retro, 9 1/4" reverse angle; Phoenix Instruments Item Number: 155-8680; Lot Numbers: 020114, 050114, 060112, 120312. 5) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Autobahn Surgical; Autobahn Surgical Product Name: Valvulotome, retro, 9 1/4" reverse angle; Autobahn Surgical Item Number: 352614A; Lot Number: 120312. 6) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Echo Instruments; Echo Instruments Product Name: Valvulotome, retro, 9 1/4" reverse angle; Echo Instruments Item Number: 558-690; Lot Number: 070513. 7) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome, retro, 9 1/4" reverse angle; Symmetry Surgical Item Number: 155-8680; Lot Numbers: 020114, 030314, 050114, 060112, 060214, 070513, 110212, 120312. 8) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Valvulotome, retro, 9 1/4" reverse angle; Millennium Surgical Item Number: 9-68680; Lot Numbers: 030314, 070513, 120312. 9) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: B.B.M. Surgical Instruments; B.B.M. Surgical Instruments Product Name: Valvulotome, retro, 9 1/4" reverse angle; B.B.M. Surgical Instruments Item Number: BBM8680; Lot Number: 060112. 10) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Valvulotome, retro, 9 1/4" reverse angle; Stealth Surgical Item Number: SSV21161; Lot Numbers: 040513, 050114, 060112, 070513, 120312. 11) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: CareFusion; CareFusion Product Name: Valvulotome, retro, 9 1/4" reverse angle; CareFusion Item Number: VM76-8161; Lot Numbers: 020114, 030314, 050114, 070513, 110212, 120312. 12) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, retro, 9 1/4"; Boss Instruments Item Number: 65-7050 ; Lot Numbers: 050214, 060112, 060214. 13) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Medline Industries; Medline Industries Product Name: VALVULOTOME, LEATHER, ANTEGRADE, 2.9 TIP 9.5"; Medline Industries Item Number: MDG0416536; Lot Number: 070513. 14) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Valvulotome, retro, 12" cut edge 2 mm; Phoenix Instruments Item Number: 155-86
Risk classification: Class II
Area (FDA): device
Country: United States

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