The Recall Desk
SevereFDA (Devices)·Z-2268-2017·Announced 2017-06-14

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
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 →