Reported Dec 3, 2014 · Terminated
Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011,…
Market-Tiers 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: Market-Tiers Inc · 8097 Flint St · Lenexa, KS · 66214-3335
Is this the product you have?
- Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.
- Lot codes and dates
- Instructions for Use V. 02.08.2012 that was provided with control units
- bearing the following serial numbers
100 of 100 codes
4861300-0026283800-0026283800-0046283800-0106283800-0236823800-0456283800-0086283800-0116283800-0137010201-0176283800-0146283800-0166283800-0176283800-0196283800-0206283800-0216283800-0226283800-0296283800-0246283800-0266283800-0276283800-0306283800-0316283800-0346283800-0376283800-0386283800-0396283800-0406283800-0426283800-0436283800-0446283800-0466283800-0476283800-0486283800-0496283800-0506929500-0026929500-0036929500-0046929500-0056929500-0066929500-0076929500-0086929500-0107010201-0027010201-0037010201-0057010201-0067010201-0077010201-0087010201-0157010201-0107010201-0137010201-0147010201-0167010201-0197010201-0187010201-0207010201-0217010201-022
- Amount recalled
- 100 units
Where it was sold
- Nationwide
Why it was recalled
Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.
This product could cause temporary or reversible health problems — stop using it.
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