CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Cardinal Health Presource Kits: 1 ) Kit, Fetal Surgery recalled
Cardinal Health 200 is recalling Cardinal Health Presource Kits: 1 ) Kit, Fetal Surgery, distributed nationwide in the US. The recall was initiated on 8 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0914-2025
- FDA event ID
- 95722
- Recalling firm
- Cardinal Health 200, Waukegan, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Nov 2024
- FDA classified
- 15 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 8 Nov 2024 | Recall initiated by company | |
| 15 Jan 2025 | Classified by FDA | +68 days |
| 22 Jan 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Cardinal Health Presource Kits: 1 ) 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
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Questions about this recall
Why was it recalled?
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Which lots are affected?
Catalog Number PB11FSC10, UDI/DI 10197106452042 (EA)50197106452040 (CS), Lot Number 6928760 ; Catalog Number PB11FSCH5, UDI/DI 10195594665951 (EA)50195594665959 (CS), Lot Number 5891312 ; Catalog Number PB11FSCH6, UDI/DI 10195594760984 (EA)50195594760982 (CS), Lot Number 6022131 ; Catalog Number PB11FSCH7, UDI/DI 10195594788704 (EA)50195594788702 (CS), Lot Number 6025788 ; Catalog Number PB11FSCH8, UDI/DI 10197106000229 (EA)50197106000227 (CS), Lot Number J6278R ; Catalog Number PB11FSCH9, UDI/DI 10197106404751 (EA)50197106404759 (CS), Lot Number 6788562 ; Catalog Number PB11FSCHR, UDI/DI 10195594890407 (EA)50195594890405 (CS), Lot Number 7280109 ; Catalog Number PB11FSCHR, UDI/DI 10195594890407 (EA)50195594890405 (CS), Lot Number 6487904 ;
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 95722This product is part of a recall event; the main page for the event is Cardinal Health Presource Kits: 1 ) Aneurysm Pack recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cardinal Health Presource Kits: 1 ) Aneurysm Pack recalled | Cardinal Health 200 | Sterility | Nationwide | |
| CLASS II | Cardinal Health Presource Kits: Kit, H N Free Flap recalled | Cardinal Health 200 | Sterility | Nationwide | |
| CLASS II | Cardinal Health Presource Kits: 1 ) Laryngoscopy Pack recalled | Cardinal Health 200 | Sterility | Nationwide | |
| CLASS II | Cardinal Health Presource Kits: 1 ) Kit, Major Oral Surgery recalled | Cardinal Health 200 | Sterility | Nationwide | |
| CLASS II | Cardinal Health Presource Kits: 1 ) Triple Endo Pack recalled | Cardinal Health 200 | Sterility | Nationwide |
More recalls from Cardinal Health 200
All 285| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Convenience Kits: KIT, Usgpiv recalled by Cardinal Health 200 | Cardinal Health 200 | Packaging Defects | Nationwide |
| Device | CLASS II | Presource Convenience Kits: KIT, PRE OP recalled by Cardinal Health 200 | Cardinal Health 200 | Packaging Defects | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
Other Other Medical Devices recalls
All 13,857| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |