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
FDA Recall Z-3254-2026 · Posted 2026-09-22
Recalling FirmCardinal Health 200, LLC
Recall StatusOpen, Classified
Product CodeLRP
Date Initiated2026-08-10
Product Quantity17503 kits
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.
Firm Action
An URGENT: PRODUCT CORRECTION notification letter dated 8/10/26 was sent to customers.
If you locate affected product within your facility, please do the following:
1. QUARANTINE affected kits.
2. ALERT your clinicians of this action.
3. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to
clinicians, instructing them to remove and discard the recalled component(s).
4. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this
action and the completion of labeling product via fax to 614.652.9648.
Additional labels will be sent to your facility upon request. Please send an email to:
[email protected]
For component credit or replacement, please contact the following:
" Hospitals Cardinal Customer Service at 866.551.0533
" Distributors Distributor Management at 800.635.6021
" Federal Government facilities Government Customer Service at 800.444.1166
If you are a Distributor and have further distributed affected kits please notify your customers of this recall.
Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.