Recall Weekly
Serious riskFDA DeviceClass I

Arrow PICC access tray recalled for possible sterility risk

Arrow International included lidocaine, bupivacaine, and saline solution from a supplier with known quality issues in PICC Access Tray kits. The supplier's products have reported cases of drug ineffectiveness, and compromised sterility in injectable medications can cause serious injury. About 360 kits with specific lot numbers were distributed nationwide.

From the FDA notice · Read the official notice ↗

What to do

  1. If you have a PICC Access Tray with lot numbers 33F25C0224, 33F25D0647, 33F25G0390, or 33F25J0348, do not use it.
  2. Contact your healthcare provider or Arrow International for instructions on safe replacement or disposal.
  3. Report any adverse effects or product issues to the FDA MedWatch program.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Description/REF: PICC ACCESS TRAY/ASK-04001-CG1
Sold in
Nationwide
Made for
All ages

This recall covers 35 products — see all of them.

Details

Units affected
360
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2395-2026

In the FDA's words

Description
Description/REF: PICC ACCESS TRAY/ASK-04001-CG1 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-CG1/10801902193275/33F25C0224, 33F25D0647, 33F25G0390, 33F25J0348 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: 360
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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