Description/ref: Hemodialysis Kit: 2l 14 FR X 20 CM AGB recall: Sterility Concern
Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A
Why was Description/ref: Hemodialysis Kit: 2l 14 FR X 20 CM AGB recalled?
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF(Material)/UDI-DI/Lot(Batch): CDC-25142-X1A/30801902123597, 10801902193275/36F25E0021, 33F25B0467
- Product
- Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A
- Recalling firm
- ARROW INTERNATIONAL, LLC
- Quantity
- 1180
- Distribution
- 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, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.
- Recall date
- June 24, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)