Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 11522558 (Centurion code 110931) contained

FDA device recall Z-2067-2019 · posted 2019-08-12 · Terminated

Recall details

Recalling firm

Medline Industries Inc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

N/A

Quantity affected

4890

Distribution

One distributor located in Illinois.

Date initiated

2019-05-10

Date posted

2019-08-12

Date terminated

2021-08-18

Location

Northfield, IL