Sterile Oxymetry Oligon Catheter Kit. Pressure recall
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Why was Sterile Oxymetry Oligon Catheter Kit. Pressure recalled?
Sterile catheter kit packaging compromised.
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?
Model: XA3816SFKT LOT CODES: 62563142, 62157774, 62132722, 62749306, 62625932
- Product
- Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 597 units
- Distribution
- US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.
- Recall date
- May 20, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)