Reported Dec 14, 2016 · Terminated
Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience…
Angiodynamics Inc. (Navilyst Medical Inc.)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Angiodynamics Inc. (Navilyst Medical Inc.) · 10 Glens Falls Tech Park · Glens Falls, NY · 12801-3864
Is this the product you have?
- Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media
- Lot codes and dates
- Batch/Lot
5057225056512
- Batch/Lot
- Amount recalled
- 75 packages (boxes of 5)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst contain an incorrect expiration date. Navilyst has confirmed that Medlines affected sterile gloves (Medline Part Number MSG1075/MSG3075) have been included in a limited number of kits.
This product could cause temporary or reversible health problems — stop using it.
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