Device 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
Z-0750-2021
Product summary
- Event
- Event 86831
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42 kits
- Official record key
device-enforcement:Z-0750-2021
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)00884450339121 Lot # T1888031,
Distribution pattern: US distribution to: KY, RI, and MD
Derived failure modes
-
Sterility assurance
compromised sterile barrier