Navilyst Medical Recalls PICC Kits Due to Potential Sterility Issues
Navilyst Medical is recalling specific PICC Convenience 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. The hazard involves potential loss of sterility due to packaging defects, which is a significant risk but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause harm).
Plain-English summary
Navilyst Medical, Inc. is recalling specific lots of PICC Convenience Kits with Accessories. The recall is being conducted because the kits contain 10 ml BD PosiFlush SF Saline Flush Syringes that were found to have open seals. This defect may impact package integrity and potentially affect the sterility of the product.
The affected product is the PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705. The specific lot number is 4753215, with an expiration date of 30-Apr-15. A total of 54 units/pouches were distributed nationwide.
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
- PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy…
- Manufacturer
- Navilyst Medical, Inc
- Category
- Medical Device — PICC Kits
- Affected units
- 54
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. 4753215 (exp. 30-Apr-15)
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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