Recall Z-1256-2021
Cardinal Health 200, LLC · initiated February 11, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
JUDKINS PACK
Codes / lots: Model SANHDJTVCF, lot 525067.
Reason for recall
Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication label sheet throughout the specific Presource kit SANHDJTVCF Judkins Pack lot # 525067.
FDA-determined cause: Process control
Action taken
The notice "Presource Kits Containing an Incorrect Medication Label Sheet" and reply form dated 02/11/2021 were sent to the customer. For questions, requiring additional labels, or desire special assistance relating to this notice, contact Cardinal Health Quality Systems at 800.292.9332.
Details
- Recall number
- Z-1256-2021
- Initiated
- February 11, 2021
- Terminated
- December 22, 2022
- Product code
- OEQ – Angiography/Angioplasty Kit
- Quantity
- 298 units
- Distribution
- US state of VA.
- Recalling firm
- Cardinal Health 200, LLC, Waukegan, IL