Double Lumen CRRT/ABP Catheter Set recall
Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15
Why was Double Lumen CRRT/ABP Catheter 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?
MCAJ510 MCAP860 MCAZ820 MCCB890 MCCJ250 MCDF160 MCDQ630 MCFF200 MCFF620 MCFK200 MCFV440 MKAK310 MCAW770 MCBW430 MCCH320 MCCJ690 MCFB450 MCFF930 MCFV450 MKAK320 MKAV210 MCAY080 MCBD600 MCBP740 MCBW440 MCCA030 MCCH330
- Product
- Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15
- 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)