Duo-Flow XTP Straight Full Set recall
Duo-Flow XTP Straight Full Set, RMS02105 RMS02108
Why was Duo-Flow XTP Straight Full Set recalled?
The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.
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?
MKAC440 MCCH440
- Product
- Duo-Flow XTP Straight Full Set, RMS02105 RMS02108
- Recalling firm
- Medical Components, Inc dba MedComp
- Quantity
- N/A
- Distribution
- Nationwide distribution; worldwide distribution.
- Recall date
- September 5, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)