Arrow International Recalls PICC Kits with Potential Peel-Away Sheath Defect
Arrow International is recalling 52,109 PICC kits because the peel-away sheath hub tabs may prematurely detach. One injury has been reported.
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 recall is classified as FDA Class II and involves a reported injury, which aligns with the 'Severe' criteria for significant injury reports or Class II recalls with adverse events.
Plain-English summary
Arrow International Inc is recalling 52,109 units of PICC Kits with Peel-Away Sheath Component. These are intravascular therapeutic ultrasound catheters used for medical procedures. The recall was initiated because the hub tabs on the catheter peel-away component may prematurely detach.
The affected products were distributed nationwide in the United States and internationally to Canada. The source text does not specify the exact dates of distribution or the specific facilities where the products were sold. The recall covers specific product codes and lot numbers listed in the official FDA record.
One injury has been reported in connection with this defect. Consumers and healthcare providers should stop using the affected PICC kits and contact Arrow International Inc for instructions on how to return the products or obtain a replacement.
The recalled product
- Product
- PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 52,109
Distribution
Distributed nationwide across the United States.
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