Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: SWAN G…
Cardinal Health 200, LLC · Kits contain infusion sets which were recalled for performance issues.
Open FDA's page for this record- Cfres ID
- 223222
- Product res number
- Z-0219-2027
- Event date initiated
- 2026-09-24
- Event date posted
- 2026-11-02
- Recall status
- Open, Classified
- Res event number
- 100058
- Product code
- OKE
- Code info
- GTIN 382602846379 (ea) 50382602846374 (cs), LOT # 761270
- 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
- Reason for recall
- Kits contain infusion sets which were recalled for performance issues.
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 112 kits
- Distribution pattern
- US and Canada
- Product description
Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: SWAN GANZ, KIT, CATALOG # PC37SGPHA
- Action
Cardinal Health issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 9/24/2026 via US Mail. The notice explained the issue and requested the discontinuation of the use of the affected BD Alaris Pump Infusion Sets as per the enclosed notice from Becton Dickinson. The notice instructed the following: 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: gmb-FieldCorrectiveAction@cardinalhealth.com 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 directed to notify their customers of the recall. For questions contact: Cardinal Health Quality Systems at 800.292.9332.
- Harmonized identifiers (openFDA)
- Device name
- Port Introducer Kit
- Medical specialty description
- General Hospital
- Regulation number
- 880.5965
- Device class
- 2
- Registration number
- 3011237770, 1061124, 1030451, 3004111573, 1220477, 3006942524, 3020460367, 2245270, 1417592, 1223004, 3009888344, 1047429, 3007329020, 8020785, 1928237, 1643817, 2029015, 1423537, 3035642068, 9616088
- FEI number
- 3011237770, 1030451, 3004111573, 1220477, 3006942524, 3002902735, 3020460367, 2245270, 1417592, 3009888344, 1047429, 3007329020, 1928237, 1643817, 3001236905, 1000120555, 1000512168, 3035642068, 3009291251, 1000160458
