Recall Weekly
Serious riskFDA DeviceClass I

Arrow peritoneal lavage kits recalled for possible sterility problem

Arrow International's 8FR peritoneal lavage catheter kits contain anesthetic medications (lidocaine and bupivacaine) from a supplier with known quality issues. If the sterility of these injectable components is compromised, patients could face serious injury or infection.

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using affected kits immediately if you have them in inventory
  2. Check your lot numbers against the FDA's list to confirm if your kits are affected
  3. Contact Arrow International or your distributor for instructions on return or replacement
  4. Do not use any affected kits on patients
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 35 products — see all of them.

Details

Units affected
7560
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2380-2026

In the FDA's words

Description
Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000 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-09000/30801902121722, 10801902193275, 20801902121756/33F24B0178, 33F24C0097, 33F24E0336, 33F24F0311, 33F24G0335, 33F24K0101, 33F24L0795, 33F25E0919, 33F25G0467, 33F25G0758, 33F25H0722, 33F25J0468, 33F25L0463, 33F26A0389, 33F24A0368 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: 7560
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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