Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Issues
Navilyst Medical is recalling BioFlo PICC kits because included BD syringes had open seals, potentially affecting sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential loss of sterility due to packaging defects, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Navilyst Medical, Inc. is recalling specific lots of BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kits. The recall involves 65 units/pouches of the 5F-55 cm sterile kits, specifically Batch/Lot No. 4752351 with an expiration date of 31-Jan-16. The products were distributed nationwide.
The recall was initiated after Navilyst Medical was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes included in the kits. The manufacturer reported that some syringe unit packages exhibited open seals. This defect may impact package integrity and potentially affect the sterility of the product.
Healthcare facilities and consumers should stop using the affected PICC kits and contact Navilyst Medical for further instructions or a replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Navilyst Medical, Inc
- Affected units
- 65
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch/Lot No. 4752351 (exp. 31-Jan-16)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Navilyst Medical, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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