The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1812-2019·Announced 2019-06-26

Arrow JACC Medical Device Recalled for Incorrect Expiration Date Labeling

Arrow International Inc is recalling 2 units of Arrow JACC with Chloraguard Technology due to an incorrect expiration date on the product label.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a minor labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the Moderate severity criteria.

Plain-English summary

Arrow International Inc is recalling 2 units of Arrow JACC with Chloraguard Technology (Product Code: JR 42041 HPHNM). The recall was initiated because the product was labeled with an incorrect expiration date.

The affected units are identified by Batch Code 13F17F0097. The distribution pattern is listed as nationwide and foreign.

Consumers and healthcare providers should check their inventory for this specific product code and batch code. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product
Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM
Affected units
2

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)

  • Batch Code: 13F17F0097

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 36 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 36 products in this recall →

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