FDAClass IISeptember 18, 2024

Medline Convenience kits labeled as: 1) INFECTION recall

Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pack Number DYNDC1960A; 3)…

Why was Medline Convenience kits labeled as: 1) INFECTION recalled?

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

DM645, Lot Number 2019120980; DYNDC1960A, Lot Number 2022040790; DYNDH1319, Lot Number 2020122250; DYNDH1324A, Lot Number 2020122250; DYNDH1514, Lot Number 2020040250; DYNDH1514, Lot Number 2020050750; DYNDH1570, Lot Number 2022011450; DYNDH1574, Lot Number 2022011450; DYNDH1596, Lot Number 2020122250; DYNDH1596, Lot Number 2022092090; DYNDH1638, Lot Number 2021062150; DYNDH1638, Lot Number 2021092350; DYNDH1638, Lot Number 2022011450; DYNDH1638, Lot Number 2022060750; DYNDH1699, Lot Number 2022060750; DYNDL1159B, Lot Number 2019022580; DYNDS1064B, Lot Number 2019062480; DYNDS1064B, Lot Number 2019120980; DYNJTS0214, Lot Number 2020113050; DYNJTS0214, Lot Number 2021012850; DYNJTS0214, Lot Number 2021050750; DYNJTS0214, Lot Number 2021082650; DYNJTS0214, Lot Number 2021102550; DYNJTS0214, Lot Number 2021111290; DYNJTS0214, Lot Number 2022040790; DYNJTS0214, Lot Number 2022052690; DYNJTS0214, Lot Number 2022080390; DYNJTS0214, Lot Number 2022092090; DYNJTS0214, Lot Number 2022102190; DYNJTS0214, Lot Number 2023100990; DYNJTS0214, Lot Number 2024010890; DYNJTS4306, Lot Number 2022011450; IVS3320, Lot Number 2021111290; P241108, Lot Number 2021012850; P268481, Lot Number 2022060750; P784604, Lot Number 2019120980; SPEC0061B, Lot Number 2021062150; SPEC0095, Lot Number 2020113050; SPEC0095, Lot Number 2022060750; SPEC0149, Lot Number 2020113050; SPEC0255, Lot Number 2019022580; SPEC0255, Lot Number 2019032580; SPEC0255, Lot Number 2019062480; SPEC0255, Lot Number 2019120980; SPEC0255, Lot Number 2019121080; SPEC0255, Lot Number 2020012080; SPEC0400, Lot Number 2020113050

Product
Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pack Number DYNDC1960A; 3)…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Distribution
Worldwide distribution.
Recall date
September 18, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls