Arrow Pressure Injectable PICC Kit Recalled for Needlestick Injury Risk
Arrow International is recalling 43,394 units of Pressure Injectable PICC Kits due to safety cover disengagement and needlestick injury reports.
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 is classified as FDA Class II and involves reports of needlestick injury, which aligns with the rubric criteria for Severe severity (FDA Class II with injury reports).
Plain-English summary
Arrow International Inc is recalling 43,394 units of 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 affected products are identified by Material Number EU-04041-HPMSB and were distributed nationwide.
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. This defect poses a risk of injury to healthcare professionals handling the devices.
Healthcare facilities and consumers should stop using the affected Arrow Pressure Injectable PICC Kits immediately. Users should contact Arrow International Inc for further instructions on how to return or dispose of the recalled products.
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 Kits
- 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-04041-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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