Reported Jan 22, 2025 · Ongoing

Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog…

Cardinal Health 200, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cardinal Health 200, LLC · 3651 Birchwood Dr · Waukegan, IL · 60085-8337

Is this the product you have?

  • Cardinal Health Presource Kits1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6 4 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH7 5 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH8 6 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH9 7 ) KIT, FETAL SURGERY , Catalog Number PB11FSCHR
Lot codes and dates

8 of 8 products

Products covered by this recall
Model / numberBarcodesProduct as published
PB11FSC101019710645204250197106452040UDI/DI 10197106452042 (EA)50197106452040 (CS), Lot Number 6928760
PB11FSCH51019559466595150195594665959UDI/DI 10195594665951 (EA)50195594665959 (CS), Lot Number 5891312
PB11FSCH61019559476098450195594760982UDI/DI 10195594760984 (EA)50195594760982 (CS), Lot Number 6022131
PB11FSCH71019559478870450195594788702UDI/DI 10195594788704 (EA)50195594788702 (CS), Lot Number 6025788
PB11FSCH81019710600022950197106000227UDI/DI 10197106000229 (EA)50197106000227 (CS), Lot Number J6278R
PB11FSCH91019710640475150197106404759UDI/DI 10197106404751 (EA)50197106404759 (CS), Lot Number 6788562
PB11FSCHR1019559489040750195594890405UDI/DI 10195594890407 (EA)50195594890405 (CS), Lot Number 7280109
PB11FSCHR1019559489040750195594890405UDI/DI 10195594890407 (EA)50195594890405 (CS), Lot Number 6487904
Amount recalled
512,786 total units

This recall covers 10 products

The agency filed one notice per product. You are reading one of them; the other 9 are below.

Where it was sold

  • Nationwide

Why it was recalled

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.