Z-0750-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 6, 2021
- Initiation Date
- November 10, 2020
- Termination Date
- October 5, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42 kits
Product Description
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
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 Pattern
US distribution to: KY, RI, and MD
Code Information
(01)00884450339121 Lot # T1888031,