An external vein stripper is an extravascular device used to remove a section of a vein sold unde...
FDA Device Recall #Z-0536-2015 — Class II — September 8, 2014
Recall Summary
| Recall Number | Z-0536-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 8, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Instrumed International, Inc. |
| Location | Schaumburg, IL |
| Product Type | Devices |
| 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
Lot / 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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|---|---|---|---|
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| Z-0534-2015 | Class II | A zipser clamp is an instrument used to compres... | Sep 8, 2014 |
| Z-0547-2015 | Class II | McKenzie enlarging burrs are bone cutting and d... | Sep 8, 2014 |
| Z-0548-2015 | Class II | Hudson cranial drill sets (w/ brace and 5 attac... | Sep 8, 2014 |
| Z-0550-2015 | Class II | Gardner-Wells traction tongs are skull tongs fo... | Sep 8, 2014 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.