Overview
A medical device recall is an action taken to correct or remove a device from the market when it may pose a health risk or fails to perform as intended. Device recalls range from a simple software patch or a labeling correction to a full removal of the product from circulation, depending on how serious the underlying issue is.
This specific medical device recall involving Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGB is classified as Class I, and was reported on June 24, 2026 by ARROW INTERNATIONAL, LLC.
The sections below explain, in plain language, what is known about this medical device recall, who it may affect, and what steps patients and caregivers can reasonably take. This article is an independent summary written for educational purposes and is not a substitute for the official FDA notice linked at the end of this page.
What Happened
ARROW INTERNATIONAL, LLC initiated action on Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGB on June 24, 2026 after identifying possible contamination or a sterility concern. The action affects specific lots or units of this device rather than every unit ever produced, so not every package on the market is necessarily involved.
The action is described in FDA records as voluntary: firm initiated, and its current status in FDA records is listed as "Ongoing". Recall status can change as the firm works through correction or removal, so the most current information is always the official FDA recall record linked below.
Affected Products
The product identified in this notice is Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGB, manufactured or distributed by ARROW INTERNATIONAL, LLC.
FDA records describe the affected product as: Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 15 CM/CDC-41552-JX1A; AGBA PI JACC KIT:…
Identifying details on record include specific lot numbers, batch codes, or serial numbers documented as REF(Material)/UDI-DI/Lot(Batch): ASK-41552-LTAC/10801902193275/33F24J0142, 33F24H0002; ASK-42063-LTAC/10801902214925/33F24F1005; CDC-41541-JX1A/10801902193275/33F25H0768; CDC-41552-JX1A/10801902193275, 10801902201505/33F25A0185, 33F25E0826, 33F24D0561; CDC-41563-JX1A/10801902193275/33F25B0150; CDC-42041-JX1A/10801902193275, 10801902188288/33F25E0751, 33F26C0353, 33F25A0186; CDC-42052-JX1A/10801902193275/33F25G0312, 33F24J0131; CDC-42063-JX1A/10801902193275/33F25C0447, 33F25D0516, 33F25E0752, 33F25J0436, 33F25C0370; a reported quantity of 1,516; distribution reported as US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI,…; origin or reporting location of Morrisville, NC, United States. If you have this product, compare it against these identifiers before assuming it is affected — many recalls apply to only a subset of lots, not an entire product line.