Recall Z-2067-2019— Medline Industries Inc
Class I · Terminated
Class I FDA medical device recall by Medline Industries Inc, initiated 2019-05-10, terminated 2021-08-18. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Medline Industries Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-05-10
- Terminated
- 2021-08-18
- Firm location
- Northfield, IL, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.