Custom procedure packs recall
Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012…
Why was Custom procedure packs recalled?
ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
a) Item Number 830015012 Lot Numbers: 72700L, 74508L b) Item Number: 830027 Lot Numbers: 72702C, 74406C c) Item Number: 830026 Lot Numbers: 72897B d) Item Number: 830024 Lot Numbers: 73325B, 74403B e) Item Number, 880189011 Lot Numbers: 73173K, 74855K f) Item Number: 830028 Lot Numbers: 73666B g) Item Number 830084 Lot Numbers: 74354B h) Item Number 830014 Lot Numbers: 74373N i) Item Number 830034 Lot Numbers: 68336D
- Product
- Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012…
- Recalling firm
- ROi CPS LLC
- Quantity
- 412 packs
- Distribution
- US: AR, OK, MO, KS
- Recall date
- February 5, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)