Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) ...
FDA Device Recall #Z-3254-2026 - Class II, August 10, 2026
Recall Summary
| Recall Number | Z-3254-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | August 10, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cardinal Health 200, LLC |
| Location | Waukegan, IL |
| Product Type | Devices |
| Quantity | 17503 kits |
Product Description
Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, PRE PROCEDURE , Catalog Number: IVSJV8302E; 4) KIT, IV SUPPLIES , Catalog Number: IVS3223531; 5) KIT, IV SUPPLIES , Catalog Number: IVS3223532; 6) KIT, IV SUPPLIES , Catalog Number: IVS3223533; 7) KIT, IV SUPPLIES , Catalog Number: IVS3223534; 8) KIT, IV SUPPLIES , Catalog Number: IVS3223535; 9) KIT, IV SUPPLIES , Catalog Number: IVS322358M; 10) KIT, IV SUPPLIES , Catalog Number: IVS322358N; 11) KIT, IV SUPPLIES , Catalog Number: IVS322358O; 12) KIT, PATIENT ADMISSIONS , Catalog Number: AMN333032A; 13) KIT, C SECTION , Catalog Number: MAT42267AL; 14) KIT, C SECTION , Catalog Number: MAT4226725; 15) KIT, VAGINAL DELIVERY , Catalog Number: MAT422677G; 16) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226792; 17) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226793; 18) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226794; 19) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226795
Reason for Recall
The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.
Distribution Pattern
US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.
Lot / Code Information
1) AMN548616A, UDI-DI: 10197106721834(each), 10197106721834(case), Lot Number: 4249818 ; 2) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5124984 ; 3) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5129488 ; 4) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5129488 ; 5) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103 ; 6) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103 ; 7) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211212 ; 8) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824 ; 9) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211985 ; 10) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226 ; 11) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824 ; 12) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103 ; 13) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211212 ; 14) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5246952 ; 15) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226 ; 16) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226 ; 17) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 6062168 ; 18) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824 ; 19) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226 ; 20) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 6062168 ; 21) BA1DH0116B, UDI-DI: 0(each), 0(case), Lot Number: 6051588 ; 22) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984 ; 23) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984 ; 24) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ; 25) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984 ; 26) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ; 27) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ; 28) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5188103 ; 29) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5195818 ; 30) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211907 ; 31) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985 ; 32) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211212 ; 33) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985 ; 34) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5279226 ; 35) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ; 36) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985 ; 37) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 6037918 ; 38) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ; 39) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5155824 ; 40) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5279226 ; 41) IVS3223531, UDI-DI: 10198956173941(each), 10198956173941(case), Lot Number: 5124984 ; 42) IVS3223532, UDI-DI: 10198956173958(each), 10198956173958(case), Lot Number: 5124984 ; 43) IVS3223533, UDI-DI: 10198956362536(each), 10198956362536(case), Lot Number: 5188103 ; 44) IVS3223533, UDI-DI: 10198956362536(each), 10198956362536(case), Lot Number: 5211985 ; 45) IVS3223534, UDI-DI: 10198956470347(each), 10198956470347(case), Lot Number: 5129488 ; 46) IVS3223534, UDI-DI: 10198956470347(each), 10198956470347(case), Lot Number: 5155824 ; 47) IVS3223534, UDI-DI: 10198956470347(each), 10198956470347(case), Lot Number: 5310701 ; 48) IVS3223535, UDI-DI: 10198956527010(each), 10198956527010(case), Lot Number: 5188103 ; 49) IVS3223535, UDI-DI: 10198956527010(each), 10198956527010(case), Lot Number: 60622168 ; 50) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818 ; 51) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4248961 ; 52) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818 ; 53) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818 ; 54) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818 ; 55) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5124984 ; 56) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 4249818 ; 57) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5124984 ; 58) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5129488 ; 59) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103 ; 60) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103 ; 61) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5195818 ; 62) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103 ; 63) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103 ; 64) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5129488 ; 65) IVS322358O, UDI-DI: 10198956517073(each), 10198956517073(case), Lot Number: 6051588 ; 66) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5248375 ; 67) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5309623 ; 68) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5309623 ; 69) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5310701 ; 70) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 6051588 ; 71) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5150160 ; 72) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5188102 ; 73) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5188103 ; 74) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5350797 ; 75) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5126398 ; 76) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5126398 ; 77) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5181074 ; 78) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5188102 ; 79) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5188102 ; 80) MAT42267AL, UDI-DI: 5276968 (each), 10198956120129(case), Lot Number: 10198956120129; 81) MAT4226725, UDI-DI: 5126398 (each), 10198956181557(case), Lot Number: 10198956181557; 82) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5126398 ; 83) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5126398 ; 84) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5129058 ; 85) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5126398 ; 86) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5210853 ; 87) MAT4226792, UDI-DI: 10198956207974(each), 10198956207974(case), Lot Number: 5129058 ; 88) MAT4226793, UDI-DI: 10198956426405(each), 10198956426405(case), Lot Number: 5350797 ; 89) MAT4226794, UDI-DI: 10198956484559(each), 10198956484559(case), Lot Number: 5309623 ; 90) MAT4226794, UDI-DI: 10198956484559(each), 10198956484559(case), Lot Number: 5310701 ; 91) MAT4226795, UDI-DI: 10198956538023(each), 10198956538023(case), Lot Number: 6051588
Other Recalls from Cardinal Health 200, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3296-2026 | Class II | Presource Packs Containing Stryker StrykeFlow P... | Aug 18, 2026 |
| Z-3298-2026 | Class II | Presource Packs Containing Stryker StrykeFlow P... | Aug 18, 2026 |
| Z-3297-2026 | Class II | Presource Packs Containing Stryker StrykeFlow P... | Aug 18, 2026 |
| Z-3295-2026 | Class II | Presource Packs Containing Stryker StrykeFlow P... | Aug 18, 2026 |
| Z-3255-2026 | Class II | Presource Convenience Kits: 1) KIT, USGPIV ... | Aug 10, 2026 |
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.