Recall Weekly
Serious riskFDA DeviceClass I

Arrow pacing kit recalled for possible loss of sterility

Arrow International included lidocaine, bupivacaine, and saline solution from a supplier with quality issues in pacing/PSI kits. The supplier's products had limited reports of drug ineffectiveness, and if the sterility of these injectable products is compromised, it could cause serious or life-threatening injury. Approximately 95 kits were distributed nationwide.

From the FDA notice · Read the official notice ↗

What to do

  1. If you have an affected kit (model ASK-07155-MGU, lot 33F25C0798), do not use it.
  2. Contact your healthcare provider or Arrow International for guidance on replacement or proper disposal.
  3. Report any adverse events 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: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 35 products — see all of them.

Details

Units affected
95
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2383-2026

In the FDA's words

Description
Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU 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-07155-MGU/10801902210217/33F25C0798 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: 95
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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