Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Do
FDA device recall Z-0009-2013 · posted 2012-10-04 · Terminated
Recall details
- Recalling firm
- Accuro Medical Product LLC
- 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 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OMP
- Quantity affected
- 919 units
- Distribution
- Worldwide distribution: USA (nationwide) and country of: Canada.
- Date initiated
- 2012-08-31
- Date posted
- 2012-10-04
- Date terminated
- 2017-12-27
- Location
- Downers Grove, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WOUND PRO APEX (K100823) | Accuro Medical Products, LLC | 2011-01-24 |