Merit Medical Systems, Inc.: 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.

Agency Publication Date: December 29, 2020

Affected Products

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

(01)00884450255803 Lot # T1883210

Lot Numbers:

T1883210

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

(01)00884450339121 Lot # T1888031,

Lot Numbers:

T1888031

Product: 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, chloraprep, table cover, and gauze to be used in a Cardiac Cath procedure.

(01)00884450515105 Lot # T1907711,

Lot Numbers:

T1907711

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86831

Status: Resolved

Manufacturer: Merit Medical Systems, Inc.

Manufactured In: United States

Units Affected: 3 products (90 kits; 42 kits; 80 kits)

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Sources: FDA iRES · Raw API Response

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Affected Products

(01)00884450255803 Lot # T1883210

Lot Numbers:

T1883210

(01)00884450339121 Lot # T1888031,

Lot Numbers:

T1888031

(01)00884450515105 Lot # T1907711,

Lot Numbers:

T1907711