Instructions for Use for the blue endo MOREsolution recall
Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control…
Why was Instructions for Use for the blue endo MOREsolution recalled?
Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control…
- Recalling firm
- Market-Tiers Inc
- Quantity
- 100 units
- Distribution
- Nationwide Distribution.
- Recall date
- December 3, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)