Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise
Navilyst Medical is recalling 51 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) poses a risk of harm by potentially affecting sterility, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Navilyst Medical, Inc. is recalling 51 units of PICC Convenience Kits with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LUMEN. The recall is limited to Batch/Lot No. 4753216 with an expiration date of April 30, 2015. These kits 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.
The affected PICC 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 Hybrid PICC, 6F-55 cm TRIPLE LUMEN, UPN Product No. H96560M0367061, REF/Catalog No. 60M036706, STERILE --- Indicated short or long-term peripheral access to the central venous system for intravenous therapy, including but not lim
- Manufacturer
- Navilyst Medical, Inc
- Category
- Medical Device — PICC Kits
- Affected units
- 51
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. 4753216 (exp.30-Apr-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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