Recall Z-1256-2021 ยท OEQ Angiography/Angioplasty Kit
Cardinal Health 200, LLC
JUDKINS PACK
| Date | Feb 11, 2021 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 298 units |
| Distribution | US state of VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.