Recall Weekly
Serious riskFDA DeviceClass I

Arrow CVC kits recalled for possible loss of sterility

Arrow International included lidocaine, bupivacaine, and saline solution from a supplier with quality issues in three models of central venous catheter (CVC) kits. The supplier's products showed limited reports of drug ineffectiveness, and compromised sterility in injectable products could cause serious injury.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have affected CVC kits: models AK-04210, AK-04300, or CK-04711
  2. Review lot numbers on affected kits against the FDA notice
  3. Contact your supplier or Arrow International for instructions on return or replacement
  4. Do not use affected kits if sterility is in question
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 35 products — see all of them.

Details

Units affected
35,540
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2396-2026

In the FDA's words

Description
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711 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-04210/10801902121582, 10801902193275/33F24A1009, 33F24B0106, 33F24C0009, 33F24D0014, 33F24G0324, 33F24J0490, 33F24K0089, 33F24L0671, 33F25A0456, 33F25C0899, 33F25E0037, 33F25H0011, 33F25J0461; AK-04300/10801902121636, 10801902193275/33F24A1257, 33F24B0435, 33F24C0734, 33F24E0704, 33F24F0011, 33F24G0224, 33F24G0684, 33F24H0373, 33F24M0148, 33F25A0364, 33F25B0084, 33F25D0193, 33F25D0693, 33F25E0479, 33F25H0686, 33F25J0587, 33F25J0651, 33F26C0397; CK-04711/20801902118787, 10801902193275/33F24A0137, 33F24A1212, 33F24B0382, 33F24C0255, 33F24E0572, 33F24G0531, 33F24J0648, 33F24L0731, 33F25A0590, 33F25C0979, 33F25E1039, 33F25J0622, 33F26B0640 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: 35,540
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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