Reported Oct 15, 2014 · Terminated
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No.…
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: Navilyst Medical, Inc · 10 Glens Falls Technical Park · Glens Falls, NY · 12801
Is this the product you have?
- BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended 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, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.
- Lot codes and dates
- Batch/Lot No. 4752351 (exp. 31-Jan-16)
- Amount recalled
- 65 units/pouches
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
Why it was recalled
NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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