Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Defects
Navilyst Medical is recalling 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile medical device where a defect may affect sterility, posing a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Navilyst Medical, Inc. is recalling specific lots of BioFlo PICC with ENDEXO 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 as having open seals. This defect may impact package integrity and potentially affect the sterility of the product.
The affected product is the BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. H965750121, REF/Catalog No. 75-012. The specific lot number is 4748676, with an expiration date of 31-Jan-16. The recall involves 125 units/pouches that were distributed nationwide.
Healthcare providers and consumers should check their inventory for this specific lot number and stop using the affected kits. The recall was initiated after the manufacturer of the syringes notified Navilyst Medical of the seal defects.
The recalled product
- Product
- BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. H965750121, REF/Catalog No. 75-012, 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
- Category
- Medical Device — PICC Kits
- Affected units
- 125
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. 4748676 (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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