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.
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 risk of harm (loss of sterility) for a medical device where injury has not yet been reported, fitting the High severity criteria.
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 Navilyst Medical was notified that some of the BD syringe unit packages exhibited open seals. These open seals may impact package integrity and potentially affect the sterility of the product. The affected PICC Kits are identified by Batch/Lot No. 4756773 with an expiration date of 31-May-15.
The recalled products were distributed nationwide. Consumers and healthcare providers 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 and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M2309831, REF/Catalog No. 60M230983, STERILE --- Indicated for short or long-term peripheral access to the central venous system for…
- Manufacturer
- Navilyst Medical, Inc
- Category
- Medical Device — PICC Kits
- Affected units
- 15
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. 4756773 (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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