Z-1256-2021Class II

Judkins Pack

Name: Z-1256-2021 Judkins Pack
Creator: Cardinal Health 200, LLC
Published: 2021-02-11
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-02-11 / Terminated / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of JUDKINS PACK on 2021-02-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1256-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-11
Posted: 2021-03-15
Terminated: 2022-12-22
Recalling firm: Medtronic, Inc.
Product: Judkins Pack
Product code: OEQ Angiography/Angioplasty Kit
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 298 units
Distribution: US state of VA.
Product codes and lots: Model SANHDJTVCF, lot 525067.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1256-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1256-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-15

Product code OEQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)