FDA Recalls Arrow PICC Catheters with Incorrect Product Code Labels
Arrow INTERNATIONAL recalled 172 units of ErgoPack PICC catheters due to incorrect product code and product name labels. The error affected lot 13F22G0508 distributed in the US.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which per the rubric requires a minimum severity score of 4 (Severe). The hazard is a labeling error that could lead to product misidentification in a medical device intended for long-term intravascular use.
Plain-English summary
Arrow INTERNATIONAL Inc. has recalled 172 units of Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC (Peripherally Inserted Central Catheter) pre-loaded with Arrow VPS TipTracker Stylet (REF CDC-45563-TTS). This is a long-term intravascular catheter device intended for use greater than 30 days.
The recall was initiated because the product code and product name were incorrectly listed on the lidstock (label) of affected kits. This labeling error could lead to misidentification of the product and its configuration.
The affected lot is 13F22G0508, which was distributed in the United States. Healthcare providers and patients should verify product identification through official documentation or contact the manufacturer for guidance.
The recalled product
- Product
- Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Hazard
- mislabeling
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 number 13F22G0508
Distribution
Distribution scope not specified by the agency.
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