FDA DevicesClass I
Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-...
Published: June 24, 2026Recall ID: Z-2382-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Morrisville |
| State | NC |
| Event id | 98793 |
| Address 1 | 3015 Carrington Mill Blvd |
| Code info | REF(Material)/UDI-DI/Lot(Batch): AK-01600/50801902120156, 10801902193275, 50801902120156, 60801902120160/33F24A0376, 33F24A1008, 33F24C0091, 33F24D0067, 33F24E0321, 33F24G0322, 33F24L0062, 33F24L0811, 33F24M0267, 33F25C0101, 33F25C0988, 33F25E0035, 33F25H0010, 33F25J0819, 33F26B0492, 33F24A0044; AK-01601/60801902120160, 10801902193275, 10801902190915/33F24A0783, 33F24A1070, 33F24C0092, 33F24E0322, 33F24G0323, 33F24J0273, 33F24L0651, 33F25C0102, 33F25C0916, 33F25E0036, 33F25G0078, 33F25J0460, 33F25L0371, 33F24B0427; ASK-01601-MM/10801902125726, 10801902193275, 10801902125726, 10801902205909/33F24F0656, 33F24K0319, 33F24M0166, 33F25A0163, 33F25E0587, 33F25G0164, 33F25L0116, 33F26A1377, 33F26C0174, 33F24F0213; AK-01000-T/10801902145120, 10801902193275, 10801902194029/33F24C0090, 33F24D0066, 33F24E0319, 33F24G0320, 33F24K0085, 33F24L0792, 33F25C0872, 33F25E0033, 33F25J0459, 33F25L0367, 33F24A0015; AK-01000/10801902197952, 10801902193275, 10801902197952, 10801902145120/33F24A0017, 33F24... [TRUNCATED] |
| Postal code | 27560-5437 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 444,943 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260421 |
| Initial firm notification | Letter |
| Center classification date | 20260612 |
Overview
- Recalling FirmARROW INTERNATIONAL, LLC
- StatusOngoing
- Risk LevelClass I
- DistributionUS 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.