Medcomp Duo-Flow 400XL Catheter recall
Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III…
Why was Medcomp Duo-Flow 400XL Catheter recalled?
Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III because the product shipped was out of specification. One BI (biological indicator) out of 21 on the sterilization load was out of specification.
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?
Medcomp products:Catalog Code/ Lot Number/Expiration Date: DFXL148MTE/ MGMC610/10/31/2019; HFS 32/ MGMB440/ 07/14/2017; HFS24E./MGLY830/07/31/2017; MC061402/MGMD190/07/15/2017; MC3L-8S/MGMD920/10/16/2019; MR17035211/MGMD680/10/31/2017; TRAY #593-3/MGMB460/07/15/2017; RMS23602/MBWM930/07/31/2017; ASPC2816-3/MBWM900/07/31/2017; Tray #55216-3/MBWL780/07/31/2017; ASPC2816-3PC/MBWX290/07/31/2017; 10301207/MGMD930/07/31/2017; 10800701/ MGLY730/ 07/31/2017; 10800702/ MGMD210/ 07/31/2017; 10800703/MGLY740/07/31/2017 AngioDynamics products- model numbers/lot numbers/ expiration dates: 10301207/MGMD930/07/31/2017; 10800701/MGLY730/07/31/2017; 10800702/MGMD210/07/31/2017; 10800703/MGLY740/07/31/2017
- Product
- Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III…
- Recalling firm
- Medical Components, Inc dba MedComp
- Quantity
- 3152
- Distribution
- Worldwide Distribution.
- Recall date
- April 8, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)