Recall Weekly
Serious riskFDA DeviceClass I

Arrow SAC kits with lidocaine, bupivacaine recalled for sterility risk

Arrow International included lidocaine, bupivacaine, and saline solutions from a supplier with quality issues in three central access kits. The supplier's quality problems and limited reports of drug ineffectiveness raise concerns that sterility may be compromised, which could lead to serious infection or other life-threatening complications.

From the FDA notice · Read the official notice ↗

What to do

  1. If you use these kits in a healthcare setting, stop using affected lots immediately
  2. Check your inventory against the lot numbers: 33F26C0515, 33F26C0517, and 33F26C0518
  3. Contact your supplier or Arrow International for instructions on returns or replacement
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; SAC KIT: 18 GA X 16CM W BIO/SAC-01618-B
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 35 products — see all of them.

Details

Units affected
0
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2390-2026

In the FDA's words

Description
Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; SAC KIT: 18 GA X 16CM W BIO/SAC-01618-B 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): SAC-01218-B/10801902225303/33F26C0515; SAC-01218-C/10801902225273/33F26C0517; SAC-01618-B/10801902225310/33F26C0518 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: 0
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.

Related topics

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