Peripherally Inserted Central Catheters recall: Labeling Error
Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits…
Why was Peripherally Inserted Central Catheters recalled?
There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with an outside diameter (OD) measuring 0.016.
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 #: 4941411
- Product
- Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits…
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Quantity
- 48 cartons (boxes of 5)
- Distribution
- Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX
- Recall date
- December 14, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)