Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS — Class I medical device recall Z-2366-2026
Ongoing recall by ARROW INTERNATIONAL, LLC, reported 2026-06-24, distributed nationwide. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits an
| Recall number | Z-2366-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ARROW INTERNATIONAL, LLC, Morrisville, NC, United States |
| Recall initiated | 2026-04-21 |
| Classified | 2026-06-12 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Quantity | 15,915 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10801902197938, 10801902203172, 10801902210217, 10801902211481, 10801902211504 |
| Lot numbers | 10801902197938/33F25B0056, 10801902203172/33F25E0208, 10801902211504/33F24G0127, 33F23L0622, 33F24D0003, 33F24H0302, 33F25B0008, 33F25C0574, 33F25D0190, 33F25D0688, 33F25E0321, 33F25E0387, 33F25E0467, 33F25E1140, 33F25E1211, 33F25G0708, 33F25H0134, 33F25H0269, 33F25H0319, 33F25H0357, 33F25J0606, 33F25J0913, 33F25L0085, 33F25L0313, 33F25M0051, 33F26A0018, 33F26A1258, 33F26A1305, 33F26A1322, 33F26B0256, 33F26B0731, 33F26B0938, 33F26C0063, 33F26C0271, 33F26C0537, AI-06210-KS/10801902210217, AI-07155-KS/10801902210217, ASK-07155-UPM/10801902210217 |
| Model numbers | 10801902197938/33F25B0056, 10801902203172/33F25E0208, 10801902211481, 10801902211504/33F24G0127, 33F23L0622, 33F24D0003, 33F24H0302, 33F25B0008, 33F25C0574, 33F25D0190, 33F25D0688, 33F25E0321, 33F25E0387, 33F25E0467, 33F25E1140, 33F25E1211, 33F25G0708, 33F25H0134, 33F25H0269, 33F25H0319, 33F25H0357, 33F25J0606, 33F25J0913, 33F25L0085, 33F25L0313 and 14 more |
Product
Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2366-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.