CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Cardinal Health Presource Kits: 1 ) Aneurysm Pack recalled
Cardinal Health 200 is recalling Cardinal Health Presource Kits: 1 ) Aneurysm Pack, 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-0910-2025
- 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 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM5; 4 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM6; 5 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM7
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 SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J5678Z ; Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number N/A ; Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J6049R ; Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J53W78 ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number J74A27 ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number J7412G ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number N/A ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number J6050A ; Catalog Number SCVHFAPBM5, UDI/DI 10888439931624 (EA)50888439931622 (CS), Lot Number J8124C ; Catalog Number SCVHFAPBM5, UDI/DI 10888439931624 (EA)50888439931622 (CS), Lot Number J8393C ; Catalog Number SCVHFAPBM5, UDI/DI 10888439931624 (EA)50888439931622 (CS), Lot Number J7905J ; Catalog Number SCVHFAPBM6, UDI/DI 10195594031701 (EA)50195594031709 (CS), Lot Number J6367G ; Catalog Number SCVHFAPBM6, UDI/DI 10195594031701 (EA)50195594031709 (CS), Lot Number J9602R ; Catalog Number SCVHFAPBM6, UDI/DI 10195594031701 (EA)50195594031709 (CS), Lot Number J9602W ; Catalog Number SCVHFAPBM7, UDI/DI 10195594127664 (EA)50195594127662 (CS), Lot Number J6367C ; Catalog Number SCVHFAPBM7, UDI/DI 10195594127664 (EA)50195594127662 (CS), Lot Number 5136034 ; Catalog Number SCVHFAPBM7, UDI/DI 10195594127664 (EA)50195594127662 (CS), Lot Number J9850D ;
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 95722| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cardinal Health Presource Kits: Kit, H N Free Flap recalled | Cardinal Health 200 | Sterility | Nationwide | |
| CLASS II | Cardinal Health Presource Kits: 1 ) Kit, Fetal Surgery 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 290| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Packs containing Medtronic Microstream Components recalled | Cardinal Health 200 | Device Malfunction | IL |
| Device | CLASS II | Presource Packs Containing Stryker StrykeFlow PS recalled | Cardinal Health 200 | Packaging Defects | Nationwide |
| Device | CLASS II | Presource Packs Containing Stryker StrykeFlow PS recalled | Cardinal Health 200 | Packaging Defects | Nationwide |
| Device | CLASS II | Presource Packs Containing Stryker StrykeFlow PS recalled | Cardinal Health 200 | Packaging Defects | Nationwide |
| Device | CLASS II | Presource Packs Containing Stryker StrykeFlow PS recalled | Cardinal Health 200 | Packaging Defects | Nationwide |
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