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STERIS CORPORATION · Model TA00001 · UDI-DI 00724995182373

FMQ
10
510(k) clearances
1,029
Adverse events (221 deaths)
33
Recalls
109
Facilities

Description

The Pair of Surgigraphic Patient Safety Straps are used with the SurgicGraphic 6000 Surgical Table.

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.