Home › Device types › FMQ
Restraint, Protective
FDA product code FMQ · Class 1 · General Hospital
3,011
Registered devices
1,027
Adverse events
33
Recalls
134
510(k) clearances
Devices with this code
Patient Safety Strap — MIZUHO ORTHOPEDIC SYSTEMS, INC.E.M. Adams Co, Inc. — E.M. ADAMS, INC.E.M. Adams Co, Inc. — E.M. ADAMS, INC.Protective Vest No Sleeve — Kenad SG Medical, Inc.E.M. Adams Co, Inc. — E.M. ADAMS, INC.MORRISON MEDICAL — MORRISON MEDICAL, LTDE.M Adams co, inc. — E.M. ADAMS, INC.E.M. Adams Co, Inc. — E.M. ADAMS, INC.E.M. Adams Co, Inc. — E.M. ADAMS, INC.MORRISON MEDICAL — MORRISON MEDICAL, LTDMORRISON MEDICAL — MORRISON MEDICAL, LTDMorrison Medical — MORRISON MEDICAL, LTDPristina Paddle — GE MEDICAL SYSTEMSE.M Adams co, inc. — E.M. ADAMS, INC.E.M Adams co, inc. — E.M. ADAMS, INC.Heelbo — D-M-S HOLDINGS, INC.E.M. Adams Co, Inc. — E.M. ADAMS, INC.DeRoyal — DEROYAL INDUSTRIES, INC.STRAP, ULTRA SHOULDER CHIN — MIZUHO ORTHOPEDIC SYSTEMS, INC.E.M Adams co, inc. — E.M. ADAMS, INC.E.M Adams co, inc. — E.M. ADAMS, INC.Protective Mitts — MEDI-TECH INTERNATIONAL CORPORATIONE.M Adams co, inc. — E.M. ADAMS, INC.MTI — Medical Technology Industries, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-15 | DeRoyal Industries Inc | The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure. |
| 2021-08-18 | Queen Comfort Products lLC | Marketed without FDA clearance |
| 2020-02-27 | DeRoyal Industries Inc | One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device. |
| 2019-04-12 | TIDI PRODUCTS | Not meeting design specifications. |
| 2015-08-19 | Med Tec Inc | The wrist straps used for positioning the patient are too long |
| 2014-12-11 | Med Tec Inc | The product (wool wrist loop) was manufactured 7cm shorter than product specifications. |
| 2014-12-11 | Med Tec Inc | The product (wool wrist loop) was manufactured 7cm shorter than product specifications. |
| 2014-02-21 | DeRoyal Industries Inc | Moldy smell in product |
| 2012-10-31 | J T Posey Company | The firm voluntarily recalled Biothane Restraint Cuffs, Catalog No. 2900, that did not meet the required specifications for tensile strength. Failure of these r |
| 2009-04-20 | J T Posey Company | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to |
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