Recall Z-0009-2013
Accuro Medical Product LLC · initiated August 31, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: part number 84635400182, serial numbers E000146 through E002039, (all serial numbers)
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0009-2013
- Initiated
- August 31, 2012
- Posted by FDA
- October 4, 2012
- Terminated
- December 27, 2017
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Quantity
- 919 units
- Distribution
- Worldwide distribution: USA (nationwide) and country of: Canada.
- Recalling firm
- Accuro Medical Product LLC, Downers Grove, IL