Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
Cardinal Health 200, LLC · Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to une…
Open FDA's page for this record- Cfres ID
- 221475
- Product res number
- Z-2944-2026
- Event date initiated
- 2026-07-14
- Event date posted
- 2026-08-13
- Recall status
- Open, Classified
- Res event number
- 99380
- Product code
- OEZ
- Product description
- Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
- Firm FEI number
- 3001236905
- Recalling firm
- Cardinal Health 200, LLC
- Address 1
- 3651 Birchwood Dr
- City
- Waukegan
- State
- IL
- Postal code
- 60085-8337
- Additional info contact
- Cardinal Health Quality Systems 800-292-9332
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 80 kits
- Distribution pattern
- US Nationwide. Canada.
- Code info
1) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15192 ; 2) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15463-1
- Reason for recall
Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.
- Action
Cardinal Health issued an URGENT: PRODUCT CORRECTION notice to its consignees on 7/14/2026 via FedEx. The notice explained the issue and enclosed a copy of the recall notice issued by the supplier of the affected component which explained the risk and provided details on the affected component. The notice issued by Cardinal Health requested that consignee notify its clinicians, affix a warning label to the affected kits in their inventory, and respond using the acknowledgement form via fax to 614.652.9648. Additional labels will be sent to your facility upon request. Please send an email to: gmb-FieldCorrectiveAction@cardinalhealth.com. The warning label requests that the affected component be removed and discarded. 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. Distributors were direct to notify their customers. For questions, additional labels, or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.
- Harmonized identifiers (openFDA)
- Device name
- Cardiovascular Procedure Kit
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1200
- Device class
- 2
- Registration number
- 3026197444, 1422634, 3013162291, 1221108, 3004911384, 3004519921, 3033589330, 3009203853, 3015225571, 3018077422, 1724474, 1043214, 9680794, 3004111573, 3002807314, 9616099, 1030451, 9616088, 1047429, 3011642792, 3014925393, 2124215, 1423395, 2029015, 3004122598, 1625425, 1423537, 1721676, 3009337401, 1016427, 1643817, 3012536737, 3007329020, 1061124, 1928237, 3017987980, 3015309643, 3015173212, 3005595283, 3005012805 +21 more
- FEI number
- 3026197444, 3003528016, 3002902735, 3013162291, 1221108, 3004911384, 3033589330, 3009203853, 3015225571, 3018077422, 1000514656, 1043214, 3004111573, 3002807314, 3014925393, 1030451, 3000717925, 1047429, 3011642792, 3002975287, 2124215, 3004122598, 3003094851, 1625425, 1000123180, 1721676, 3009337401, 1016427, 1000112968, 1643817, 3012536737, 3007329020, 1928237, 3017987980, 3015309643, 3015173212, 3005595283, 3005012805, 1721504, 1000112877 +21 more