FDA Device Recall Z-0009-2013: Accuro Medical Product LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0009-2013.

Recall Res Number

Z-0009-2013

Recalling Firm / Manufacturer

Accuro Medical Product LLC

FEI Number

3007793449

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2012-08-31

Date Posted

2012-10-04

Date Terminated

2017-12-27

Product Code

OMP

Event Number

63064

Product Quantity

919 units

Product Description 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.

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.

Action Details 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; (customer.service@accuromedical.com) 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.

Distribution Pattern Worldwide distribution: USA (nationwide) and country of: Canada.

Code Information / Serial Numbers part number 84635400182, serial numbers E000146 through E002039, (all serial numbers)

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Medical Device Recall: Z-0009-2013

Recall Parameters & Description

Related Establishments / Registrations

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