The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2336-2017·Announced 2017-06-21

Arrow Multi-Lumen CVC Kit Recalled by FDA for Medical Device Safety

Arrow International Inc is recalling Arrow Multi-Lumen CVC Kits under FDA Class II recall Z-2336-2017. The devices are used for short-term central venous access.

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 is classified as FDA Class II, which typically involves a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report specific injuries or illnesses, placing it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Arrow International Inc is recalling Arrow Multi-Lumen CVC Kits, which are medical devices used to provide short-term central venous access for the treatment of diseases or conditions requiring such access. The recall is classified as Class II by the U.S. Food and Drug Administration under recall number Z-2336-2017.

The affected devices are indicated for multiple infusions of fluids, medications, or chemotherapy, infusion of hypertonic or hyperosmolar fluids, frequent blood sampling, and central venous pressure monitoring. The source text does not specify the exact defect or reason for the recall, nor does it report any specific injuries or illnesses associated with the use of these devices.

A total of 27,485 units were distributed in the U.S. and 4,371 units were distributed internationally. The distribution pattern includes nationwide distribution in the U.S. and Canada. Consumers and healthcare providers should check their inventory for the specific material numbers listed in the recall notice and follow instructions from the recalling firm or the FDA regarding the disposition of these devices.

The recalled product

Product
Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation.
Manufacturer
Arrow International Inc
Category
Medical Device — Central Venous Catheter
Hazard

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 (6)

  • Material number: CDC-12703-1A
  • CDC-12802-1A
  • CDC-15703-1A
  • CDC-15703-B1A
  • CDC-15802-1A
  • Device Listing E426708

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 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 12 products in this recall →

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