Recall Z-1988-2013 ยท FPX Strip, Adhesive, Closure, Skin
Aspen Surgical Products, Inc.
Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strip
| Date | Aug 20, 2013 (initiated Jul 18, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| Action | 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 Co |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K874813 | OMED WOUND CLOSURE STRIPS Oxboro Medical Intl., Inc., Jan 29, 1988 |