Z-2067-2019Class I

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

Name: Z-2067-2019 Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 11522558 (Centurion code 110931)...
Creator: Medline Industries Inc
Published: 2019-05-10
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2019-05-10 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 11522558 (Centurion code 110931) contained inside kits DYNJ52509A and DYNJ52510A... on 2019-05-10. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2067-2019
Classification: Class I
Status: Terminated
Initiated: 2019-05-10
Posted: 2019-08-12
Terminated: 2021-08-18
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: N/A
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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 [email protected] or fax 866-767-1290. Customers with questions may call 1-866-359-1704.
Quantity in commerce: 4890
Distribution: One distributor located in Illinois.
Product codes and lots: lots 2018090590 2018112190 2018090690 2018101190 2018101590 2018121190 2019013190 2019030490 2019040190

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2067-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2067-2019	Class I	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)