Navilyst Medical Recalls Port Kits Due to Sterilization Barrier Breach
Navilyst Medical is recalling 920 Port Kits with Access Infusion Sets due to a possible breach of the sterilization barrier. The devices were distributed nationwide.
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 is classified as FDA Class II. The hazard involves a potential breach of the sterilization barrier, which poses a risk of infection or harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Navilyst Medical, Inc. is recalling 920 units of Port Kits with Access Infusion Sets. The recall is due to a possible breach of the sterilization barrier, which could compromise the sterility of the device.
The affected products include various configurations of 8F and 6F ports made of plastic or titanium, with or without valves. Specific product numbers and catalog numbers are listed in the official recall notice. The devices are indicated for long-term access to the central venous system for the administration of fluids, chemotherapy, and other medical treatments.
The recalled products were distributed nationwide in the United States, including in California, Connecticut, the District of Columbia, Massachusetts, New Jersey, New York, Pennsylvania, Maryland, Virginia, West Virginia, North Carolina, Georgia, Florida, Tennessee, Ohio, Minnesota, Montana, Illinois, Missouri, Nebraska, Oklahoma, Texas, New Mexico, and Washington. Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice and contact Navilyst Medical for further instructions.
The recalled product
- Product
- Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog Num
- Manufacturer
- Navilyst Medical, Inc.
- Category
- Medical Device — Implanted Port
- Affected units
- 920
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 (20)
- Batch/Lot Numbers: 4688881
- 4688883
- 4688884
- 4688885
- 4688887
- 4668695
- 4654060
- 4659108
- 4668699
- 4654061
- 4659109
- 4668700
- 4654062
- 4659110
- 4668701
- 4654063
- 4658398
- 4662581
- 4664985
- 4675021
Distribution
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