Recall Z-0751-2021 — Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angioplasty. The contents of the kit are surgical drapes, gowns, towels, medicine cups, needles, various bowls, pen and label set (PAL), scalpel, several syringes, ch
U.S. FDA — Device Enforcement · United States · 2020-11-10 · Class II
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Reported risk: Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment.
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