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Terminated

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 Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples

FDA Recall Z-1988-2013 · Posted 2013-08-20

Recalling FirmAspen Surgical Products, Inc.
Recall StatusTerminated
Product CodeFPX
Date Initiated2013-07-18
Date Terminated2014-04-17
Product Quantity3286 boxes ( 6,353,000)

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.

Firm 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 [email protected] or Michelle Pulaski, Quality System and Compliance Manager 888-364-7004 ext 146 [email protected] 8-5 EST M-F.

Root Cause

Process design

Distribution Pattern

Worldwide Distribution - US Nationwide in the state of Florida and in the countries of , Netherlands, and Reditch Worcestershire England

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K874813OMED WOUND CLOSURE STRIPSOxboro Medical Intl., Inc. · 1988-01-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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