Premicath 28G PICC Catheter recallZ-0090-06 · Vygon Corporation · initiated Jun 27, 2005
Terminated All recalls posted in October 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Vygon Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Guidewire protuding from tip of the catheter
FDA root cause category: Other
What the company is doing
The recalling firm issued a recall letter via fax to the distributors on 6/27/05. The letter informed the distributors of the problem and to notify any hospital accounts of the problem and the need to trim the catheter prior to implantation.
Recall details
- Recall number
- Z-0090-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 27, 2005
- Posted by the FDA
- Oct 28, 2005
- Recalling firm
- Vygon Corporation
- Quantity
- 243 units
- Product code
- LJS
- FDA submissions
- K041468
- Distribution
- The product was shipped to distributors in CA, CO, FL, IL, MD, NJ, NY, OH, PA, TX and WA.
Product description
Premicath 28G PICC Catheter
Code information (models, lots, serial numbers)
Lot numbers 014434 and 012615
Other devices under the same FDA submission
1 device cleared under K041468 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- VYGON 1261.203AVygon Corporation · Catheter, intravascular, therapeutic, long-term greater than 30 days1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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