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.
Hazard
Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.
What You Should Do
Remedy
The recalling firm issued a letter dated 7/16/14 via Federal Express requesting the customer destroy the incorrect IFU and replace it with the corrected version.
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Products
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, s
- Brand
- Market-Tiers Inc
- UPC
- Instructions for Use V. 02.08.2012 that was provided with control units bearing the following serial numbers: 4861300-002, 6283800-002, 6283800-004, 6283800-010, 6283800-023, 6823800-045, 6283800-008, 6283800-011, 6283800-013, 7010201-017, 6283800-014, 6283800-016, 6283800-017, 6283800-019, 6283800-020, 6283800-021, 6283800-022, 6283800-029, 6283800-024, 6283800-026, 6283800-027, 6283800-030, 6283800-031, 6283800-034, 6283800-037, 6283800-038, 6283800-039, 6283800-040, 6283800-042, 6283800-043, 6283800-044, 6283800-046, 6283800-047, 6283800-048, 6283800-049, 6283800-050, 6929500-002, 6929500-003, 6929500-004, 6929500-005, 6929500-006, 6929500-007, 6929500-008, 6929500-010, 7010201-002, 7010201-003, 7010201-005, 7010201-006, 7010201-007, 7010201-008, 7010201-015, 7010201-010, 7010201-013, 7010201-014, 7010201-016, 7010201-019, 7010201-018, 7010201-020, 7010201-021, 7010201-022, 7010201-023, 7010201-024, 7686200-010, 7010201-025, 7686200-002, 7686200-003, 7686200-006, 7686200-004, 7686200-007, 7686200-008, 7686200-024, 7686200-009, 7686200-017, 7686200-011, 7686200-012, 7686200-013, 7686200-014, 7686200-015, 7686200-016, 7686200-018, 7686200-019, 7686200-020, 7686200-023, 7686200-025, 8037400-001, 8037400-002, 8037400-006, 8037400-004, 8037400-012, 8037400-005, 8037400-007, 8037400-011, 8037400-018, 8037400-008, 8037400-010, 8037400-013, 8037400-014, 8037400-017, 8037400-003, and 8374200-008
Units Affected
100 units