Arrow International Recalls Pressure Injectable PICC Kits Due to Needlestick Risk
Arrow International is recalling Pressure Injectable PICC Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
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 involves a risk-of-harm product (needlestick injury) where injury has been reported, but the source does not specify FDA Class I or fatalities, fitting the High severity criteria for reported injuries without critical classification.
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 specific material number for the affected units is EU-05541-HPMSB.
The recall was initiated due to reports of safety cover disengagement and needlestick injury associated with the BD Eclipse Needle. These needles are packaged with certain Arrow products. The source text does not specify the number of affected units or the exact dates of distribution, though the distribution pattern is listed as nationwide.
Healthcare facilities and consumers should stop using the affected Arrow Pressure Injectable PICC Kits immediately. Users should contact Arrow International Inc for instructions on how to return or dispose of the product. This recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Arrow Pressure Injectable PICC Kit The Arrow International 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 — PICC Kit
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 EU-05541-HPMSB
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 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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