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
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 potential loss of sterility in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
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 subject to a separate recall by the manufacturer, BD.
The recall was initiated after BD notified Navilyst that some syringe unit packages exhibited open seals. This defect may impact package integrity and potentially affect the sterility of the product. The affected PICC Kits are identified by Batch/Lot No. 4753765 with an expiration date of 31-May-15.
The affected products were distributed nationwide. These kits are indicated for short or long-term peripheral access to the central venous system for intravenous therapy. Consumers and healthcare providers should stop using the affected lots and contact Navilyst Medical for further instructions.
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. H96560M0224751, REF/Catalog No. 60M022475, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intrave
- Manufacturer
- Navilyst Medical, Inc
- Category
- Medical Device — PICC Line
- 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. 4753765 (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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