Arrow Recalls PICC Kits Due to Potential Packaging Seal Defects
Arrow International is recalling Pressure Injectable PICC Kits because packaging may not be completely sealed, potentially compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device where a packaging defect may compromise sterility, creating a risk of harm (infection) even though specific injuries or illnesses have not been reported in the source text.
Plain-English summary
Arrow International is recalling the Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology. The recall is being conducted because the packaging for these devices may not be completely sealed, which may compromise the sterility of the product.
The affected product is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and central venous pressure monitoring. The recall includes 27,485 units distributed in the U.S. and 4,371 units distributed internationally, with distribution patterns covering the U.S. (nationwide) and Canada.
Healthcare providers and consumers should check their inventory for the affected material number ASK-45552-RWJ4 and Device Listing D213817. If the product is found, it should be removed from use and returned to the manufacturer or the point of purchase in accordance with the recall instructions.
The recalled product
- Product
- 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — PICC Kit
- Hazard
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)
- Material number: ASK-45552-RWJ4 Device Listing D213817
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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