FDA recall Z-0749-2021

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

Reason for recall

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.

Distribution

US distribution to: KY, RI, and MD

Key facts

Status

Terminated

Initiation date

2020-11-10

Report date

2021-01-06

Termination date

2022-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

South Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0749-2021