Reported Aug 28, 2013 · Terminated
Distributed in USA
Aspen Surgical Products, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aspen Surgical Products, Inc. · 6945 Southbelt Dr Se · Caledonia, MI · 49316-7664
Is this the product you have?
Distributed in USA
3 of 3 products
| Model / number | Product as published |
|---|---|
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) |
40-2893 | 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 : 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 |
- Lot codes and dates
- Product 40-2894Lot Numbers/Expiration Date Lot Numbers/Expiration"
102 of 102 codes
2690-0907302014-072690-1111282016-112690-0912072014-122690-1112052016-122690-1003092015-032690-296612017-012690-1004072015-042690-297752017-012690-1004292015-042690-1203072017-032690-1005052015-052690-1204102017-032690-1006032015-062690-1204252017-042690-1006072015-062690-1205172017-052690-1006152015-062690-1208032017-082690-1006172015-062690-1208222017-082690-1007092015-072690-1209172017-092690-1007282015-072690-1210192017-102690-1010012015-102690-1211062017-102690-1011012015-112690-1211052017-112690-1011172015-112690-1211282017-11
- Product 39-0058 (outside USA)Lot Numbers/ Expiration Date"
113052016-05117312017-03119742017-08123532018-04
- Product 40-2893 (outside USA)Lot Numbers/ Expiration Date
104252014-11105042014-07107272015-02111782015-10111792015-12112602016-01112612016-02115582016-07
- Product 40-2894Lot Numbers/Expiration Date Lot Numbers/Expiration
- Amount recalled
- 3286 boxes ( 6,353,000)
Where it was sold
- Nationwide
- FL
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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