The Recall Desk
ModerateFDA (Devices)·Z-2724-2014·Announced 2014-10-08

Instrumed Recalls Reusable Laparoscopic Instruments for Updated Safety Instructions

Instrumed International is recalling 3,093 reusable laparoscopic instruments to add caution statements regarding voltage limits and useful life to the Instructions For Use.

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 and involves the addition of caution statements to the Instructions For Use to prevent potential tissue carbonation and ensure devices are not used beyond their useful life. No illnesses or injuries are reported in the source text, and the hazard is mitigated by updated labeling and usage limits, fitting the criteria for a moderate severity recall involving labeling and usage safety.

Plain-English summary

Instrumed International, Inc. is recalling 3,093 reusable laparoscopic instruments distributed nationwide. The recall is initiated to add additional caution statements to the Instructions For Use (IFU) for monopolar electrodes. The updated instructions specify that to avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. Additionally, the IFU now states that the useful life of the product is less than or equal to 50 cycles and less than or equal to 2 years.

The affected instruments are intended to be used by qualified physicians to provide access, illumination, and visualization of internal structures and for manipulating soft tissue in diagnostic and therapeutic laparoscopic or urologic procedures. The devices are packaged as non-sterile and require cleaning and sterilization prior to use. The recall covers specific lot numbers and catalog codes listed in the agency's structured data, distributed across numerous US states.

Healthcare facilities and users should stop using the affected instruments and contact Instrumed International for further instructions regarding the updated documentation.

The recalled product

Product
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manip
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
3,093

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 Item No.: 250-08570
  • CareFusion Catalog Code: VM46-9112-1
  • Lot Number: 010111
  • 2) Instrumed Item No.: 250-08600
  • CareFusion Catalog Code: LA8523
  • Lot Number: 070211
  • 070213
  • 090412
  • 3) Instrumed Item No.: 250-08610
  • CareFusion Catalog Code: LA8523-45
  • Lot Number: 042011
  • 062209
  • 4) Instrumed Item No.: 250-08620
  • CareFusion Catalog Code: LA8515
  • Lot Number: 030511
  • 040310
  • 080111
  • 5) Instrumed Item No.: 250-08630
  • CareFusion Catalog Code: LA8515-45
  • Lot Number: 050212

Distribution

Distributed nationwide across the United States.

The notice also names 45 states specifically:

Part of a larger recall action

This product is one of 10 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 10 products in this recall →

Related recalls

Same manufacturer · Instrumed International, Inc.

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Same hazard · tissue carbonation

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