NEO-KATH(TM) Caudal Set recall
NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Why was NEO-KATH(TM) Caudal Set recalled?
Potential for stylet to protrude from the distal end of the catheter
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?
Reference Number 201-2430, Lot Numbers 16308139 (Expiration August 2022), 16308383 (Expiration October 2022)
- Product
- NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
- Recalling firm
- Epimed International
- Quantity
- 140 units
- Distribution
- Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.
- Recall date
- August 25, 2021
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)