—#185851

Product

JUDKINS PACK

FDA product code: OEQ — Angiography/Angioplasty Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Model SANHDJTVCF, lot 525067.

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: US state of VA.

Timeline

Recall initiated: 2021-02-11
Terminated: 2022-12-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185851. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.