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Heelbo

D-M-S HOLDINGS, INC. · Model D 12069 · UDI-DI 00767056950696

FMQ Prescription
10
510(k) clearances
1,027
Adverse events (221 deaths)
33
Recalls
109
Facilities

Description

Limbo Snap Hook Limb Restraint Large

Recalls

DateFirmReason
2022-07-15DeRoyal Industries IncThe webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
2021-08-18Queen Comfort Products lLCMarketed without FDA clearance
2020-02-27DeRoyal Industries IncOne lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
2019-04-12TIDI PRODUCTSNot meeting design specifications.
2015-08-19Med Tec IncThe wrist straps used for positioning the patient are too long
2014-12-11Med Tec IncThe product (wool wrist loop) was manufactured 7cm shorter than product specifications.
2014-12-11Med Tec IncThe product (wool wrist loop) was manufactured 7cm shorter than product specifications.
2014-02-21DeRoyal Industries IncMoldy smell in product
2012-10-31J T Posey CompanyThe 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
2009-04-20J T Posey CompanyPosey 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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Data 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.