POWERWAND XL 4Fr 8cm Maximum Barrier Kit recall: Labeling Error
POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No.…
Why was POWERWAND XL 4Fr 8cm Maximum Barrier Kit recalled?
Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user dissatisfaction or annoyance.
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?
Lot number 269939, 270552, 270874, and 272261.
- Product
- POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No.…
- Recalling firm
- Access Scientific LLC
- Quantity
- 1710
- Distribution
- US Nationwide distribution including in the state of NY.
- Recall date
- July 22, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)