Arrow Pressure Injectable PICC Kit Recalled for Needlestick Injury Risk
Arrow International is recalling 43,394 units of Pressure Injectable PICC Kits nationwide due to reports of safety cover disengagement and needlestick injuries.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a Class II medical device with reported needlestick injuries, which constitutes significant injury reports under the severity rubric.
Plain-English summary
Arrow International Inc. has initiated a nationwide recall of 43,394 units of the Arrow Pressure Injectable PICC Kit. The affected product is identified by material number EU-05541-HPMSB. This medical device is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
The recall was initiated due to reports of safety cover disengagement and needlestick injury associated with the BD Eclipse Needle packaged with certain Arrow products. The source text does not specify the number of reported injuries or the specific dates of the incidents.
Healthcare facilities and consumers who have this product should stop using it immediately. Arrow International Inc. is the recalling firm responsible for managing the recall. Users should contact the manufacturer or their medical device supplier for instructions on how to return or dispose of the affected units.
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 — IV Catheters
- Affected units
- 43,394
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.
See all 56 products in this recall →Related recalls
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Similar recalls
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