Agency classClass IIOur severity:High FDA (Devices)·Z-2262-2017·Announced 2017-06-14

Arrow PICC Kit Recall Due to Needlestick Injury Risk

Arrow International is recalling specific PICC kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.

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 3/5 (High).

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 classification or fatalities, fitting the High severity criteria for reported injury without critical classification.

Plain-English summary

Arrow International Inc. has initiated a recall of 43,394 units of the Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology. The recall is due to reports of safety cover disengagement and needlestick injury associated with the BD Eclipse Needle that is packaged with these specific Arrow products.

The affected product is identified by Material Number ASK-45552-SPH. These kits are indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and central venous pressure monitoring. The recall covers units distributed nationwide.

Healthcare providers and consumers should stop using the affected PICC kits immediately. Users should contact Arrow International Inc. for further instructions on how to return or dispose of the recalled devices.

The recalled product

Product: Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure injectable P1CC with chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for…
Manufacturer: Arrow International Inc
Category: Medical Device — PICC Kit
Hazard: needlestick-injury
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 ASK-45552-SPH

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 →

Same manufacturer · Arrow International Inc

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Same hazard · needlestick injury