Arrow Pressure Injectable PICC Kit Recalled for Quality Concerns
Arrow International Inc. is recalling Arrow Pressure Injectable PICC Kits due to a Class II recall classification. The devices are used for intravenous therapy and blood sampling.
What this means for you
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 is classified as FDA Class II. According to the rubric, FDA Class II recalls without explicit reports of hospitalization or significant injury are typically scored as High (3), representing a risk of temporary or medically reversible health consequences.
Plain-English summary
Arrow International Inc. is recalling Arrow Pressure Injectable PICC Kits. These medical devices are intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
The recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not specify the exact defect or the specific reason for the recall beyond the classification. The recall number is Z-2338-2017.
A total of 27,485 units were distributed in the U.S. and 4,371 units were distributed internationally. The distribution pattern includes the U.S. (nationwide) and Canada. The affected material numbers are EU-04041-HPMSB, EU-05052-HPMSB, and EU-05041-HPMSB. The Device Listing number is D000801.
Healthcare providers and consumers should check their inventory for these specific material numbers. If the device is in use, they should contact the manufacturer or their supplier for instructions on replacement or return. The source text does not provide specific consumer action steps beyond the standard recall protocol.
The recalled product
- Product
- Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- 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 (3)
- Material number: EU-04041-HPMSB
- EU-05052-HPMSB
- EU-05041-HPMSB Device Listing D000801
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.
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