The Recall Desk
SevereFDA (Devices)·Z-2067-2019·Announced 2019-08-21

Medline Centurion Convenience Kits Recalled for Infusion Set Defect

Medline is recalling Centurion Convenience Kits containing BD Alaris Pump Infusion Sets due to a tubing defect that may cause over-infusion of medication.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies this as a sub-recall to a Class I recall, and the rubric mandates a score of at least 4 for FDA Class I classifications.

Plain-English summary

Medline Industries Inc is recalling 4,890 units of Centurion Convenience Kits, specifically kits DYNJ52509A and DYNJ52510A, which contain BD Alaris Pump Infusion Sets. The affected products are identified by BD code 11522558 (Centurion code 110931) and specific lot numbers listed in the recall notice. These kits are used to continuously or intermittently deliver fluids, medications, blood, and blood products to adult, pediatric, or neonatal patients.

The recall is a sub-recall to a recent Class I recall by BD for the Alaris Pump Infusion Set. The defect involves the consistency of the inner lumen thickness of the silicone tubing segment. This issue impacts the amount of occlusion force necessary to fully seal the tube, preventing the pump from achieving complete occlusion. As a result, there is a potential for over-infusion of drug product into the patient.

The affected products were distributed to one distributor located in Illinois. Healthcare facilities and distributors should stop using the affected kits and contact Medline Industries Inc for instructions on how to return or dispose of the products.

The recalled product

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 intermitt
Affected units
4,890

Distribution

Distributed in 1 state: