Home / Recalls / Instrumed International, Inc. / Z-0536-2015

Z-0536-2015 Class II Terminated

Recalled by Instrumed International, Inc. — Schaumburg, IL

Recall Details

Product Type
Devices
Report Date
December 17, 2014
Initiation Date
September 8, 2014
Termination Date
November 29, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
479 valvulotomes

Product Description

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.

Reason for Recall

The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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

Distribution Pattern

Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

Code Information

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: 155-8682; Lot Number: 070212. 15) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Autobahn Surgical; Autobahn Surgical Product Name: Valvulotome, retro, 12" cut edge 2 mm; Autobahn Surgical Item Number: 352613A; Lot Number: 070212. 16) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Medsaver M S I Precision; Medsaver M S I Precision Product Name: Valvulotome, retro, 12" cut edge 2 mm; Medsaver M S I Precision Item Number: 421637J; Lot Number: 110212. 17) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome, retro, 12" cut edge 2 mm; Symmetry Surgical Item Number: 55-8682; Lot Numbers: 020413, 030314, 050114, 060413, 070212, 100313, 110212. 18) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Surgical Direct; Surgical Direct Product Name: Valvulotome, retro, 12" cut edge 2 mm; Surgical Direct Item Number: 9-68680001; Lot Numbers: 060413, 100313. 19) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Valvulotome, retro, 12" cut edge 2 mm; Millennium Surgical Item Number: SD8121.103; Lot Numbers: 050114, 060413. 20) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: CareFusion; CareFusion Product Name: Valvulotome, retro, 12" cut edge 2 mm; CareFusion Item Number: VM76-8163; Lot Numbers: 020413, 030314, 050114, 060413, 070212, 080111, 100313, 110212. 21) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, retro, 12"; Boss Instruments Item Number: 65-7052; Lot Numbers: 050114, 060413. 22) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Valvulotome, ante, 6 1/4"; Phoenix Instruments Item Number: 155-8681; Lot Number: 080111. 23) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome, ante, 6 1/4"; Symmetry Surgical Item Number: 55-8681; Lot Numbers: 030314, 040214, 060413, 070212, 080111, 120413. 24) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Valvulotome, ante, 6 1/4"; Millennium Surgical Item Number: 9-68681; Lot Numbers: 040214, 060413. 25) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: B.B.M. Surgical Instruments; B.B.M. Surgical Instruments Product Name: Valvulotome, ante, 6 1/4"; B.B.M. Surgical Instruments Item Number: BBM8681; Lot Number: 050312. 26) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Valvulotome, ante, 6 1/4"; Stealth Surgical Item Number: SSV21162; Lot Numbers: 060413, 070212. 27) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: CareFusion; CareFusion Product Name: Valvulotome, ante, 6 1/4"; CareFusion Item Number: VM76-8162; Lot Numbers: 030314, 040214, 060413, 120413. 28) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: Medline Industries; Medline Industries Product Name: Valvulotome, ante, 6 1/4"; Medline Industries Item Number: MDG546940; Lot Number: 060413. 29) Instrumed Product Name: Valvulotome, ante, 7"; Instrumed Product Number: 500-05660; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, ante, 7"; Boss Instruments Item Number: 65-7051-7; Lot Numbers: 050314, 100313. 30) Instrumed Product Name: Valvulotome 9 1/4" Antegrade; Instrumed Product Number: 500-05664; Trade Name: Autobahn Surgical; Autobahn Surgical Product Name: Valvulotome 9 1/4" Antegrade; Autobahn Surgical Item Number: 352612A; Lot Number: 090412. 31) Instrumed Product Name: Valvulotome 9 1/4" Antegrade; Instrumed Product Number: 500-05664; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome 9 1/4" Antegrade; Symmetry Surgical Item Number: 55-8684; Lot Numbers: 020311, 070513, 090412. 32) Instrumed Product Name: Valvulotome 9 1/4" Antegrade; Instrumed Product Number: 500-05664; Trade Name: CareFusion; CareFusion Product Name: Valvulotome 9 1/4" Antegrade; CareFusion Item Number: VM76-8150; Lot Numbers: 070513, 090412, 100513. 33) Instrumed Product Name: Valvulotome 9 1/4" Antegrade; Instrumed Product Number: 500-05664; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, ante, 9 1/4"; Boss Instruments Item Number: 65-7049; Lot Number: 070513. 34) Instrumed Product Name: Valvulotome 9 1/4" Antegrade; Instrumed Product Number: 500-05664; Trade Name: Medline Industries; Medline Industries Product Name: Valvulotome, Antegrade 9 1/4" ; Medline Industries Item Number: MDG0416566; Lot Number: 090412. 35) Instrumed Product Name: Valvulotome Antegrade, 12"; Instrumed Product Number: 500-05669; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome Antegrade, 12" ; Boss Instruments Item Number: 65-7053; Lot Numbers: 020114, 050114, 050312, 060413, 090412. 36) Instrumed Product Name: Valvulotome Antegrade, 12"; Instrumed Product Number: 500-05669; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Valvulotome Antegrade, 12" ; Phoenix Instruments Item Number: 155-8683; Lot Number: 060413. 37) Instrumed Product Name: Valvulotome Antegrade, 12"; Instrumed Product Number: 500-05669; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome Antegrade, 12" ; Symmetry Surgical Item Number: 55-8683; Lot Number: 020114, 050312, 060413.

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