Unrated Medical device recall · FDA · Published November 16, 2018

Cardinal Health Presource Kit Total Joint Pack Recall: Sterility Risk

Cardinal Health recalls Presource Kit Total Joint Pack with double-wrapped basin component due to sterility assurance validation issues. Affected units sold with specific lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0702-2019Medical device Cardinal Health ›

Recall notice

The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.

Take action

Contact the company

Recalling firmCardinal Health Inc.7000 Cardinal Pl · Dublin, OH 43017-1091

✎ GovInfoNow plain-language explainer

Cardinal Health is recalling Presource Kit Total Joint Pack products that contain a double-wrapped basin component. This recall is due to a potential sterility risk that could affect patient safety during joint replacement procedures. Read more at govinfonow.com/recall/69461-cardinal-health-presource-kit-total-joint-pack-recall-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/69461-cardinal-health-presource-kit-total-joint-pack-recall-sterility-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0702-2019

Cite this page

“Cardinal Health Presource Kit Total Joint Pack Recall: Sterility Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69461-cardinal-health-presource-kit-total-joint-pack-recall-sterility-risk. Based on FDA recall #Z-0702-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0702-2019%22&limit=1).

Cardinal Health Inc. voluntarily recalled Presource Kit Total Joint Pack containing a double-wrapped basin component on Nov. 16, 2018, according to the FDA. The hazard is that the double wrapping is not supported by current sterility assurance validation.

How to tell if you have it

Brand: Cardinal Health
Product: Presource Kit Total Joint Pack
Product code: SOP22TJCLK
Lot numbers: # 104405, 122793, and 987948
Quantity: 182 packs
Distribution: US state of Florida

The hazard

The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation. The FDA said the product is used on patients undergoing joint replacement knee or hip.

Context

GovInfoNow's records show Cardinal Health Inc. has 11 other recalls on record since 2019-11-14. Other recent recalls of similar products include Xolair 75mg Injection Recall (2025-07-30), Wegovy injection recall (2025-04-09), and Enoxaparin 30mg Syringes Recall (2025-08-05).

How to tell if you have this one

Check for lot numbers 104405, 122:2793, and 987948 on the Presource Kit Total Joint Pack. The product is used for joint replacement knee or hip surgeries.

Brand
Cardinal Health
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Numbers
Look for lot numbers 104405, 122793, or 987948 on the Presource Kit Total Joint Pack.

Where it went and when

Where it was distributed

Distributed in Florida.

FDA distribution: “US state of Florida” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

Nov 16, 2018Firm started the recall
Jan 9, 2019FDA classified it Class II
Jan 16, 2019Published in FDA’s Enforcement Report
Nov 4, 2019FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Cardinal Health recalls

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Keep exploring

More Cardinal Health recalls

Link to this recall

<a href="https://govinfonow.com/recall/69461-cardinal-health-presource-kit-total-joint-pack-recall-sterility-risk">Cardinal Health Presource Kit Total Joint Pack Recall: Sterility Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0702-2019 (November 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0702-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.