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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product 40-2894: Lot Numbers/Expiration Date Lot Numbers/Expiration 2690-090730 2014-07 2690-111128 2016-11 2690-091207 2014-12 2690-111205 2016-12 2690-100309 2015-03 2690-29661 2017-01 2690-100407 2015-04 2690-29775 2017-01 2690-100429 2015-04 2690-120307 2017-03 2690-100505 2015-05 2690-120410 2017-03 2690-100603 2015-06 2690-120425 2017-04 2690-100607 2015-06 2690-120517 2017-05 2690-100615 2015-06 2690-120803 2017-08 2690-100617 2015-06 2690-120822 2017-08 2690-100709 2015-07 2690-120917 2017-09 2690-100728 2015-07 2690-121019 2017-10 2690-101001 2015-10 2690-121106 2017-10 2690-101101 2015-11 2690-121105 2017-11 2690-101117 2015-11 2690-121128 2017-11 2690-101221 2015-12 2690-130107 2018-01 2690-110121 2016-01 2690-130103 2018-01 2690-110201 2016-02 2690-130109 2018-01 2690-110217 2016-02 2690-130215 2018-02 2690-110223 2016-02 2690-130307 2018-03 2690-110310 2016-03 2690-130213 2018-02 2690-110328 2016-03 2690-130306 2018-03 2690-110415 2016-04 2690-130403 2018-04 2690-110426 2016-04 2690-130409 2018-04 2690-110511 2016-02 2690-130415 2018-04 2690-120804 2017-08 " Product 39-0058 (outside USA): Lot Numbers/ Expiration Date 11305 2016-05 11731 2017-03 11974 2017-08 12353 2018-04 " Product 40-2893 (outside USA): Lot Numbers/ Expiration Date 10425 2014-11 10504 2014-07 10727 2015-02 11178 2015-10 11179 2015-12 11260 2016-01 11261 2016-02 11558 2016-07
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
Product 40-2894: Lot Numbers/Expiration Date Lot Numbers/Expiration 2690-090730 2014-07 2690-111128 2016-11 2690-091207 2014-12 2690-111205 2016-12 2690-100309 2015-03 2690-29661 2017-01 2690-100407 2015-04 2690-29775 2017-01 2690-100429 2015-04 2690-120307 2017-03 2690-100505 2015-05 2690-120410 2017-03 2690-100603 2015-06 2690-120425 2017-04 2690-100607 2015-06 2690-120517 2017-05 2690-100615 2015-06 2690-120803 2017-08 2690-100617 2015-06 2690-120822 2017-08 2690-100709 2015-07 2690-120917 2017-09 2690-100728 2015-07 2690-121019 2017-10 2690-101001 2015-10 2690-121106 2017-10 2690-101101 2015-11 2690-121105 2017-11 2690-101117 2015-11 2690-121128 2017-11 2690-101221 2015-12 2690-130107 2018-01 2690-110121 2016-01 2690-130103 2018-01 2690-110201 2016-02 2690-130109 2018-01 2690-110217 2016-02 2690-130215 2018-02 2690-110223 2016-02 2690-130307 2018-03 2690-110310 2016-03 2690-130213 2018-02 2690-110328 2016-03 2690-130306 2018-03 2690-110415 2016-04 2690-130403 2018-04 2690-110426 2016-04 2690-130409 2018-04 2690-110511 2016-02 2690-130415 2018-04 2690-120804 2017-08 " Product 39-0058 (outside USA): Lot Numbers/ Expiration Date 11305 2016-05 11731 2017-03 11974 2017-08 12353 2018-04 " Product 40-2893 (outside USA): Lot Numbers/ Expiration Date 10425 2014-11 10504 2014-07 10727 2015-02 11178 2015-10 11179 2015-12 11260 2016-01 11261 2016-02 11558 2016-07
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1988-2013
Related Recalls
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Aspen Surgical Products
Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Aspen Surgical Products
Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
Aspen Surgical Products
Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.