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U.S. Department of Health and Human Services

Class 1 Device Recall Centurion Primary Set Pack Convenience Kit, Centurion Primary Warmer Pack Convenience Kit

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  Class 1 Device Recall Centurion Primary Set Pack Convenience Kit, Centurion Primary Warmer Pack Convenience Kit see related information
Date Initiated by Firm May 10, 2019
Date Posted August 12, 2019
Recall Status1 Terminated 3 on August 18, 2021
Recall Number Z-2067-2019
Recall Event ID 82951
Product Classification unknown device name - Product Code N/A
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.
Code Information lots 2018090590 2018112190 2018090690 2018101190 2018101590 2018121190 2019013190 2019030490 2019040190 
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
Manufacturer 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.
FDA Determined
Cause 2		 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 recalls@medline.com or fax 866-767-1290. Customers with questions may call 1-866-359-1704.
Quantity in Commerce 4890
Distribution One distributor located in Illinois.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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