Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Issues
Navilyst Medical is recalling specific BioFlo PICC kits because they contain BD syringes with open seals that may compromise 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) may affect sterility, posing a risk of harm, but the source text does not report any illnesses or injuries.
Plain-English summary
Navilyst Medical, Inc. is recalling specific lots of BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kits. The recall is limited to units containing 10 ml BD PosiFlush SF Saline Flush Syringes from specific lots that were recalled by the syringe manufacturer.
The recall was initiated after Navilyst Medical was notified that some of the included syringe unit packages exhibited open seals. These open seals may impact package integrity and potentially affect the sterility of the product.
The affected product is the BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023. The specific batch/lot number is 4767162 with an expiration date of 30-JUN-15. The product was distributed nationwide. Healthcare facilities and consumers should stop using the affected kits and contact Navilyst Medical for further instructions.
The recalled product
- Product
- BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the
- Manufacturer
- Navilyst Medical, Inc
- Category
- Medical Device — PICC Line
- Affected units
- 20
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. 4767162 (exp. date 30-JUN-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.
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