Device 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.
Z-0751-2021
Product summary
- Event
- Event 86831
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80 kits
- Official record key
device-enforcement:Z-0751-2021
Official wording
Reason: 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.
Code information: (01)00884450515105 Lot # T1907711,
Distribution pattern: US distribution to: KY, RI, and MD
Derived failure modes
-
Sterility assurance
compromised sterile barrier