FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
- Recall number
- Z-2944-2026
- Recalling firm
- Cardinal Health 200, LLC
- Product
- Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
- Status
- Open, Classified
- Initiated
- 2026-07-14
- Posted
- 2026-08-13
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 80 kits
- Distribution
- US Nationwide. Canada.
- Lot, serial or model codes
- 1) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15192 ; 2) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15463-1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OEZ
- Firm FEI
- 3001236905
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28