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Merit Medical Systems, Inc. recalls Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/an
Recalled January 6, 2021 · FDA recall Z-0749-2021 · Merit Medical Systems
Hazard
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. · FDA Class II
Units
90 kits
Sold at
US distribution to: KY, RI, and MD
Description
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.
Product
Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringes, table covers, stopcocks, inflation device, and gauze
Manufacturer(s)
Merit Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →