FDA-Device2026-06-24Class IPROCESSING DEFECT

Arrow International drainage and thoracentesis kits recalled for potentially non-sterile anesthetic injectables

OTHERNationwide distributionMedical devices

What this means

Arrow International included anesthetic medications (lidocaine and bupivacaine) and saline solution from a supplier with quality issues in multiple drainage, thoracentesis, and pneumothorax kits. If these injectable products lost sterility during manufacturing or storage, they could cause serious infection or treatment failure.

Check if your facility has any of the affected kit models: AK-01600, AK-01601, ASK-01601-MM, AK-01000-T, AK-01000, ASK-01000-CHP, ASK-01000-NW, ASK-01000-UPMS, AK-01500, ASK-01500, or ASK-01500-JCM
Do not use the recalled kits; contact Arrow International or your supplier for replacement or credit
Review lot numbers (beginning 33F or 33R) on packaging to confirm if your stock is affected

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The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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 count

444,943

Manufactured in

3015 Carrington Mill Blvd, Morrisville, NC, United States

Products

Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, THORACENTESIS KIT/AK-01000, THORACENTESIS KIT/ASK-01000-CHP, DRAINAGE KIT/ASK-01000-NW, THORACENTESIS KIT/ASK-01000-UPMS, PNEUMOTHORAX KIT/AK-01500, PNEUMOTHORAX KIT (NO HEIMLICH VALVE)/ASK-01500, PNEUMOTHORAX KIT/ASK-01500-JCM

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2382-2026

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