Navilyst Medical Recalls PICC Kits with Compromised Sterility
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 sterile medical device where a defect (open seals) potentially affects sterility, creating a risk of harm (infection) even though no specific injuries are reported in the text.
Plain-English summary
Navilyst Medical, Inc. is recalling specific lots of PICC Convenience Kits with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN. The recall involves 84 units/pouches distributed nationwide. The specific batch/lot number is 4754060, with an expiration date of 31-May-15.
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.
The affected PICC kits are intended for short or long-term peripheral access to the central venous system for intravenous therapy. Users should check their inventory for the specific lot number and stop using any affected units.
The recalled product
- Product
- PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog No. 60M131847, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, incl
- Manufacturer
- Navilyst Medical, Inc
- Category
- Medical Device — PICC Line
- Affected units
- 84
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. 4754060 (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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