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STERIS CORPORATION · Model Restraint Strap · UDI-DI 00724995157869
10
510(k) clearances
1,029
Adverse events (221 deaths)
33
Recalls
109
Facilities
Description
The Wristlets with Straps and Brackets are leather wristlets support and secure wrists and forearms while patient is in supine operative position.
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 rivets could allow th |
| 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 limit a patient's m |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.