The Recall Desk
HighFDA (Devices)·Z-0009-2013·Announced 2012-10-10

Accuro Wound Pro Apex Negative Pressure Wound Therapy Pump Recall

Accuro Medical Products is recalling 919 Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pumps because they may fail to operate or malfunction without notifying the user.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device malfunction that could compromise wound treatment without user notification, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Accuro Medical Products LLC is recalling 919 units of the Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump (part number 84635400182). These pumps are sold inside the Apex Negative Wound Therapy system (part number 84635400181) and are used to promote wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure.

The recall was initiated after Accuro received reports that some Apex Pumps either failed to operate or malfunctioned. In some instances, the unit's display screen did not notify the user of the failure or malfunction. The affected units have serial numbers ranging from E000146 through E002039.

The affected products were distributed nationwide in the United States and in Canada. Consumers and healthcare providers should check their serial numbers and contact Accuro Medical Products for further instructions on how to proceed with the recall.

The recalled product

Product
Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through dr
Manufacturer
Accuro Medical Product LLC
Category
Medical Device — Wound Care
Hazard
Affected units
919

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 (3)

  • part number 84635400182
  • serial numbers E000146 through E002039
  • (all serial numbers)

Distribution

Distributed nationwide across the United States.

Related recalls

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