Z-0009-2013Class II

Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854...

Name: Z-0009-2013 Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854...
Creator: Accuro Medical Product LLC
Published: 2012-08-31
License: https://open.fda.gov/license/

Pensar Medical / initiated 2012-08-31 / Terminated / root cause: design

FDA source

Accuro Medical Product LLC began a recall of Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number... on 2012-08-31. FDA classified it as Class II and gives the reason as "Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0009-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-31
Posted: 2012-10-04
Terminated: 2017-12-27
Recalling firm: Pensar Medical
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 drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Product code: OMP Negative Pressure Wound Therapy Powered Suction Pump
Reason for recall: Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Accuro, sent an "Urgent: Medical Device Recall" letter dated August 30, 2012 to the customers via e-mail on August 31, 2012. The letter describes the product, problem and actions to be taken. The customers were instructed to remove all devices from use immediately; to immediately complete and return the enclosed Accuro response form via email to; ([email protected]) or fax to: (1-800-866-0545) . Note: the form still needs to be returned even if you no longer have or use the device. Upon receipt, Customer Service will call the account with instructions to arrange for all devices to be returned to Accuro. General questions were directed to Customer Service at 1-800-669-4757.
Quantity in commerce: 919 units
Distribution: Worldwide distribution: USA (nationwide) and country of: Canada.
Product codes and lots: part number 84635400182, serial numbers E000146 through E002039, (all serial numbers)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0009-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0009-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-10-04

Product code OMP

K100823Class IIWound Pro ApexAccuro Medical Products, LLC / cleared 2011-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)