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Merit Medical Systems, Inc. recalls Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121
Recalled January 6, 2021 · FDA recall Z-0750-2021 · 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
42 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: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121 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 →