Arrow JACC Medical Device Recalled for Incorrect Expiration Date
Arrow International Inc. is recalling 3 units of Arrow JACC with Chloragard Technology due to an incorrect expiration date.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation issue (incorrect expiration date) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging or documentation problems.
Plain-English summary
Arrow International Inc. is recalling 3 units of Arrow JACC with Chloragard Technology (Product Code: JR 42563 HPHNM). The recall is being conducted because the product has an incorrect expiration date.
The affected units are identified by Batch Code 13F17F0099. The distribution pattern is listed as Nationwide and Foreign.
Consumers and healthcare providers should stop using the affected units and contact the recalling firm for further instructions.
The recalled product
- Product
- Arrow¿ JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Infusion Pumps
- Hazard
- Affected units
- 3
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: 13F17F0099
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.
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