| | Class 2 Device Recall JUDKINS PACK |  |
| Date Initiated by Firm | February 11, 2021 |
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| Create Date | March 15, 2021 |
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| Recall Status1 |
Terminated 3 on December 22, 2022 |
| Recall Number | Z-1256-2021 |
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| Recall Event ID |
87343 |
| Product Classification |
Angiography/angioplasty kit - Product Code OEQ
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| Product | JUDKINS PACK |
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| Code Information |
Model SANHDJTVCF, lot 525067. |
| FEI Number |
3001236905
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Recalling Firm/
Manufacturer |
Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
|
| For Additional Information Contact |
800-635-6021 |
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Manufacturer 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 2 | Process control |
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| 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. |
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| Quantity in Commerce | 298 units |
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| Distribution | US state of VA. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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