Recall Z-0216-2027 ยท LRO General Surgery Tray
Cardinal Health 200, LLC
Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) KIT,C SECTION ADMIT,, CATALOG # MATJV8300D; 2) KIT,C SECTION ADMIT,, CATALOG # MATJV8300C; 3) KIT, EMERGENCY C SECTION ADMIT, CATALOG # MAT216337B; 4) IN PATIENT KIT , CATALOG # PG21OTAUHA.
| Date | Nov 2, 2026 (initiated Sep 24, 2026) |
| Status | Open, Classified |
| Reason | Kits contain infusion sets which were recalled for performance issues. |
| Root cause | Nonconforming Material/Component |
| 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 r |
| Quantity | 3702 units |
| Distribution | US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.