Neonatal PICC Tray recall: Sterility Concern
Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.
Why was Neonatal PICC Tray recalled?
Potential friction holes may affect the sterility of the product.
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: 17C060D UDI: 08498840010563
- Product
- Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.
- Recalling firm
- Vygon U.S.A.
- Quantity
- 16520 total products
- Distribution
- Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
- Recall date
- May 16, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)