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. The hazard involves potential loss of sterility due to packaging defects, which is a moderate risk without reported injuries or hospitalizations.
Plain-English summary
Navilyst Medical, Inc. is recalling specific PICC Convenience Kits with Accessories. The affected products are the BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, sterile. The recall involves 3 units/pouches with Batch/Lot No. 4763165 (exp. 31-May-15). 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.
This recall is classified as Class II by the FDA. Consumers and healthcare providers 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. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801
- Manufacturer
- Navilyst Medical, Inc
- Category
- Medical Device — PICC Kits
- Affected units
- 3
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. 4763165 (exp. 31-May-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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