Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Issues
Navilyst Medical is recalling specific BioFlo PICC kits because they contain BD syringes with open seals that may compromise 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, but the source text describes a potential sterility issue due to packaging defects without reporting any specific illnesses or injuries, 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 and PASV Valve Technology Maximal Barrier Nursing Kits. The recall is being conducted because the kits contain 10 ml BD PosiFlush SF Saline Flush Syringes that have been identified with open seals.
The manufacturer of the syringes notified Navilyst Medical that the open seals on the syringe unit packages may impact package integrity and potentially affect product sterility. The affected PICC kits are distributed nationwide and include Batch/Lot Nos. 4745699 and 4760237, both with an expiration date of 31-Jan-16.
Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected kits. The recall involves 300 units/pouches of the sterile medical device intended for peripheral access to the central venous system.
The recalled product
- Product
- BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy…
- Manufacturer
- Navilyst Medical, Inc
- Category
- Medical Device — PICC Line
- Affected units
- 300
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 Nos. 4745699 (exp. 31-Jan-16) and 4760237 (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.
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