Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 m
FDA device recall Z-1988-2013 · posted 2013-08-20 · Terminated
Recall details
- Recalling firm
- Aspen Surgical Products, Inc.
- Reason for recall
- Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indicated the product may not be sterile. Using the recalled product could lead to infection which may require further treatment including the use of antibiotics. There have been no reports of injuries or illnesses as of 7/18/2013.
- Action taken
- Aspen sent an Urgent Medical Device Recall letter dated July 18, 2013 via certified mail to all customers with directions to forward the notification and provide Aspen with sub-account information. Aspen has given the customers the option to either 1.) Return the product 2.) Destroy the product with a Certificate of Destruction to be provided to Aspen. Any returned product to Aspen will be put on MRB and dispositioned by Quality. Questions or concens should be addresses to Kelli Jona Directo of QA / RA at 888-364-7004 ext 177 jonask@aspensurgical.com or Michelle Pulaski, Quality System and Compliance Manager 888-364-7004 ext 146 pulaskim@aspensurgical.com 8-5 EST M-F.
- Root cause
- Process design
- Status
- Terminated
- Product code
- FPX
- Quantity affected
- 3286 boxes ( 6,353,000)
- Distribution
- Worldwide Distribution - US Nationwide in the state of Florida and in the countries of , Netherlands, and Reditch Worcestershire England
- Date initiated
- 2013-07-18
- Date posted
- 2013-08-20
- Date terminated
- 2014-04-17
- Location
- Caledonia, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OMED WOUND CLOSURE STRIPS (K874813) | Oxboro Medical Intl., Inc. | 1988-01-29 |