Recall Weekly
Serious riskFDA DeviceClass I

Arrow hemodialysis kit recalled for possible sterility risk

Arrow International included injectable medications (lidocaine, bupivacaine, and sodium chloride) from a supplier with quality problems into hemodialysis kits. The supplier's products may not be sterile or effective, which could cause serious injury if used.

From the FDA notice · Read the official notice ↗

What to do

  1. If you received or used one of these kits (lot numbers 36F25E0021 or 33F25B0467), contact Arrow International or your healthcare provider immediately.
  2. Do not use affected kits. Affected units were distributed nationwide.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

This recall covers 35 products — see all of them.

Details

Units affected
1180
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2372-2026

In the FDA's words

Description
Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A 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. REF(Material)/UDI-DI/Lot(Batch): CDC-25142-X1A/30801902123597, 10801902193275/36F25E0021, 33F25B0467 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. Affected quantity: 1180
Hazard
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.

35 products in this recall

Arrow kits with lidocaine and bupivacaine recalled for sterility risk

Arrow is recalling 35 kits and sets that contain lidocaine, bupivacaine, or 0.9% sodium chloride from a supplier that was itself recalled for quality issues. If the sterility of these water-based injectable drugs is compromised, it could lead to serious or life-threatening injuries. No injuries have been reported, and the products were distributed nationwide.

The agency lists each product separately. Check every one you might have.

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