The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2278-2017·Announced 2017-06-14

Arrow International Recalls Multi-Lumen CVC Kits Due to Needlestick Risk

Arrow International is recalling specific multi-lumen central venous catheter kits because packaged BD Eclipse Needles 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 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 source explicitly reports needlestick injuries, which constitutes significant injury reports, meeting the criteria for a Severe (4) rating.

Plain-English summary

Arrow International Inc. has initiated a recall of the AGB+ Pressure Injectable Multi-Lumen CVC Kit. These kits are intended to permit venous access to the central circulation via the femoral, jugular, or subclavian veins. The specific material number affected is CA-42703-P1A.

The recall was initiated due to reports of safety cover disengagement and needlestick injury associated with the BD Eclipse Needle, which is packaged with certain Arrow products. The source text does not specify the number of units affected or the number of reported injuries.

Healthcare facilities and consumers should stop using the affected kits and contact Arrow International for further instructions on return or replacement.

The recalled product

Product
AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins

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 CA-42703-P1A

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 →

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