—#173181

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.

FDA product code: N/A
Affected lot / code info: lots 2018090590 2018112190 2018090690 2018101190 2018101590 2018121190 2019013190 2019030490 2019040190

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On May 10, 2019, the firm notified its distributor, Medline, of the recall. The distributor was asked to identify all inventory within its possession, and to cease further distribution. The distributor was asked to notify any customers to whom the recalled product had been distributed, and to instruct customers to cease use immediately. On May 13, 2019, Medline notified its customers of the recall. Medline's instructions to customers were as follow: 1. Immediately check your stock for the specific kit number and the affected kit lot number in the attached list. Quarantine any kits with the listed lot numbers. If you dont have any of the lots listed above skip to step 3. 2. Affix the enclosed stickers on the affected kits and return to stock. If additional stickers are needed please call 866-359-1704. Please be sure NOT to use the recalled Infusion Set components, pull another approved product from sterile supply. 3. Please fill out and return the enclosed Verification Form via email to recalls@medline.com or fax 866-767-1290. Customers with questions may call 1-866-359-1704.

Recalling firm

Firm: Medline Industries Inc
Address: Three Lakes Drive, Northfield, Illinois 60093

Distribution

Distribution pattern: One distributor located in Illinois.

Timeline

Recall initiated: 2019-05-10
Posted by FDA: 2019-08-12
Terminated: 2021-08-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173181. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.