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Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE E...

FDA Device Recall #Z-0909-2025 — Class II — November 8, 2024

Recall Summary

Recall Number Z-0909-2025
Classification Class II — Moderate risk
Date Initiated November 8, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cardinal Health 200, LLC
Location Waukegan, IL
Product Type Devices
Quantity 512,786 total units

Product Description

Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:; 3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:; 4 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMO:; 5 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMP:;

Reason for Recall

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

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Lot / Code Information

Catalog Number SBAOCTEHH1, UDI/DI 10195594722685 (EA)50195594722683 (CS), Lot Number 21J2883 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1029 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1029 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 23F1437 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 23F1437 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18E1332 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18H2278 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18J2582 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18M3535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18M3535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19A0124 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19E1525 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19K3308 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number N/A ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19K3308 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19C0888 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18H2278 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19C0888 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19A0124 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19B0560 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SEN15SERM5, UDI/DI 10195594423469 (EA)50195594423467 (CS), Lot Number 5533336 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J3987C ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J43U74 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J46A98 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J46C04 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J72P53 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J8393W ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J6050H ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J86T82 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number 5140356 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number 5891304 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number 6264567 ; Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number 6928759 ; Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number 7163104 ; Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number 7331342 ; Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number 7332908 ;

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Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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