Z-0751-2021 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
- 80 kits
Product Description
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.
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)00884450515105 Lot # T1907711,