Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise
Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.
What this means for you
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 and involves a potential sterility issue due to packaging defects, which fits the criteria for moderate severity involving low-risk contamination or precautionary measures without reported injuries.
Plain-English summary
Navilyst Medical, Inc. is recalling specific lots of PICC Convenience Kits with Accessories. The recall is initiated because these kits contain 10 ml BD PosiFlush SF Saline Flush Syringes that were recalled by the manufacturer due to open seals on some unit packages. This defect may impact package integrity and potentially affect product sterility.
The affected product is the PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN. The specific lot number is 4754052, with an expiration date of 30-Apr-15. The recall involves 60 units/pouches and was distributed nationwide.
Healthcare providers and consumers should stop using the affected PICC kits and contact Navilyst Medical for further instructions or replacement.
The recalled product
- Product
- PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0501981, REF/Catalog No. 60M050198, STERILE --- Intended for short or long-term peripheral access to the central venous system for intraven
- Manufacturer
- Navilyst Medical, Inc
- Category
- Medical Device — PICC Kits
- Affected units
- 60
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. 4754052 (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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