Recall Weekly
Serious riskFDA DeviceClass I

Arrow ASK-04001-MC3 access tray recalled for sterility risk

Arrow International's ACCESS TRAY kits (model ASK-04001-MC3) contain injectable anesthetic and saline solutions from a supplier with documented quality issues. If the sterility of these water-based injectables has been compromised, serious or life-threatening infections could result. The supplier also reported limited cases of drug ineffectiveness.

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using affected ACCESS TRAY kits immediately if you have them.
  2. Check your inventory for model ASK-04001-MC3 and cross-reference against recalled lot numbers.
  3. Contact Arrow International or your supplier for instructions on return or safe disposal.
  4. Consult your healthcare facility's pharmacy or compliance officer for next steps.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Description/REF: ACCESS TRAY/ASK-04001-MC3
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

This recall covers 35 products — see all of them.

Details

Units affected
8,265
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2392-2026

In the FDA's words

Description
Description/REF: ACCESS TRAY/ASK-04001-MC3 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): ASK-04001-MC3/ 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: 8,265
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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