Recall Weekly
Serious riskFDA DeviceClass I

Arrow paracentesis kit recalled for possible sterility risk

Arrow International included anesthetic drugs (lidocaine and bupivacaine) and saline solution from a supplier with quality problems into paracentesis kits. The supplier had reports of drug ineffectiveness, and if the sterility of these injectable products was compromised, patients could face serious injury.

From the FDA notice · Read the official notice ↗

What to do

  1. If you have kit ASK-00376-JHH (lots 33F25G0629 or 33F24K0592), do not use it.
  2. Contact Arrow International or your healthcare facility for instructions on replacement or safe disposal.
  3. Healthcare providers should quarantine affected kits and review patient records for any kits already used.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Description/REF: PARACENTESIS KIT/ASK-00376-JHH
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 35 products — see all of them.

Details

Units affected
180
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2386-2026

In the FDA's words

Description
Description/REF: PARACENTESIS KIT/ASK-00376-JHH 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-00376-JHH/10801902193275/33F25G0629, 33F24K0592 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: 180
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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