Arrow PICC Catheters Recalled for Incorrect Product Label Information
Arrow International recalled 1,173 PICC line units due to incorrect product code and name on packaging labels. Affected lot 33F23B0781 was 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: FDA Class I medical device recalls carry a minimum severity score of 4 per the rubric, regardless of whether injuries have been reported. Although the specific issue is limited to incorrect labeling on packaging rather than a functional defect, the FDA Class I classification requires this severity level.
Plain-English summary
Arrow International Inc. is recalling 1,173 units of Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet (REF CDC-45552-VPS2). These are long-term intravascular catheters intended for medical use. The affected lot number is 33F23B0781.
The recall was initiated because the product code and product name were incorrectly listed on the lidstock (packaging label) of affected kits. This labeling error could create confusion about product identification and specifications.
All affected units from lot 33F23B0781 were distributed in the United States.
Healthcare facilities and providers in possession of affected units should discontinue use and contact Arrow International for return or replacement instructions. No injuries or adverse events related to this labeling issue have been reported to the manufacturer or the FDA as of the recall notice.
The recalled product
- Product
- Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Hazard
- labeling-error
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 33F23B0781
Distribution
Distribution scope not specified by the agency.
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