Device product
Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 11522558 (Centurion code 110931) contained inside kits DYNJ52509A and DYNJ52510A. Product Usage: The Centurion Primary Set Pack and Primary Warmer Pack Convenience Kit helps continuously or intermittently deliver fluids, medications, blood and blood products to adult, pediatric or neonatal patients.
Z-2067-2019
Product summary
- Event
- Event 82951
- Status
- Terminated
- Classification
- Class I
- Quantity
- 4890
- Official record key
device-enforcement:Z-2067-2019
Official wording
Reason: This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to an issue with the consistency of the inner lumen thickness of the silicone tubing segment which directly impacts amount of occlusion force necessary to fully seal the tube. This defect prevents the pump from complete occlusion and results in the potential for over-infusion of drug product into the patient.
Code information: lots 2018090590 2018112190 2018090690 2018101190 2018101590 2018121190 2019013190 2019030490 2019040190
Distribution pattern: One distributor located in Illinois.
Derived failure modes
-
Unknown
This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to an issue with the consistency of the inner lumen thickness of the silicone tubing segment which directly impacts amount of occlusion force necessary to fully seal the tube. This defect prevents the pump from complete occlusion and results in the potential for over-infusion of drug product into the patient.