Port Kit with Access Infusion Set under the following recall
Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2)…
Why was Port Kit with Access Infusion Set under the following recalled?
Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.
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?
Batch/Lot Numbers: 4688881, 4688883, 4688884, 4688885, 4688887, 4668695, 4654060, 4654060, 4659108, 4668699, 4654061, 4659109, 4668700, 4654062, 4659110, 4668701, 4654063, 4658398, 4662581, 4664985, 4675021, 4681156, 4654064, 4654065, 4658399, 4658400, 4662583 and 4675023
- Product
- Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2)…
- Recalling firm
- Navilyst Medical, Inc.
- Quantity
- 920 Total kits
- Distribution
- US Nationwide Distribution in the states of CA, CT, DC, MA, NJ, NY, PA, MD, VA, WV, NC, GA, FL, TN, OH, MN, MT, IL, MO, NE, OK, TX, NM, and WA.
- Recall date
- February 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)