The Recall Desk
ModerateFDA (Devices)·Z-0536-2015·Announced 2014-12-17

Instrumed Recalls External Vein Strippers Due to Regulatory Non-Compliance

Instrumed International is withdrawing 479 external vein strippers because the company did not market them before 1976, failing to meet FDA pre-amendment requirements.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates the reason is regulatory non-compliance regarding pre-amendment status rather than a physical defect or reported injury, fitting the criteria for a voluntary precautionary or minor compliance recall.

Plain-English summary

Instrumed International, Inc. is voluntarily withdrawing 479 external vein strippers from the market. These devices, used to remove sections of veins, are sold under various brand names including Symmetry Surgical, CareFusion, and Boss Instruments. The affected units were distributed nationwide to locations in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia.

The recall was initiated because Instrumed did not market these specific devices prior to September 26, 1976. Consequently, the company does not meet all FDA requirements to market these devices as "Pre-Amendment" devices. This is a regulatory compliance issue rather than a report of a specific physical defect or injury.

Healthcare facilities and distributors should stop using the affected devices and contact Instrumed International for further instructions. Consumers who may have purchased these devices should check their records for the specific lot numbers and product codes listed in the official recall notice and contact the manufacturer if they possess the affected items.

The recalled product

Product
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, Me
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
479

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • 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
  • Trade Name: Boss Instruments
  • Boss Instruments Product Name: Valvulotome
  • retro
  • 6 1/4"
  • Boss Instruments Item Number: 65-7048
  • 070513
  • 110411. 4) Instrumed Product Name: Valvulotome
  • 9 1/4" reverse angle

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 28 recalled by Instrumed International, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 28 products in this recall →

Related recalls

Same manufacturer · Instrumed International, Inc.

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Same hazard · regulatory non compliance

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