Recall Weekly
Serious riskFDA DeviceClass I

Arrow paracentesis kits recalled for possible sterility risk

Arrow International paracentesis kits (models AK-00376 and ASK-00376-VCU) contain anesthetic and saline solutions from a supplier with quality issues and reports of drug ineffectiveness. If the sterility of these injectable products is compromised, they could cause serious or life-threatening infections or complications during the procedure.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have one of the affected kits by matching the lot number on the package to the FDA recall notice.
  2. Do not use affected kits. Contact your healthcare facility or supplier for replacement kits.
  3. Report any adverse events or product problems to the FDA MedWatch program or Arrow International.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
Sold in
Nationwide
Made for
All ages (under 120 years)

This recall covers 35 products — see all of them.

Details

Units affected
50,724
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2363-2026

In the FDA's words

Description
PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU 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): AK-00376/10801902197938, 10801902193275, 10801902197938, 10801902197952/33F24D0004, 33F24E0166, 33F24G0318, 33F24J0486, 33F24K0083, 33F24L0725, 33F25A0453, 33F25A0610, 33F25C0749, 33F25C0906, 33F25E0031, 33F25G0075, 33F25H0007, 33F25H0719, 33F25J0739, 33F25J0817, 33F25L0462, 33F25M0954, 33F26B0949, 33F26C0575, 33F24A0016; ASK-00376-VCU/10801902193275, 10801902138788/33F24L0522, 33F24M0088, 33F25C0060, 33F25D0282, 33F25F0257, 33F25G0746, 33F25J0602, 33F24D0201 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: 50,724
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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