Data Foundry

Medical device recalls 2026

5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis… — Class II medical device recall Z-2661-2026

Ongoing recall by Bard Access Systems, Inc., reported 2026-07-08, distributed nationwide. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain

Recall numberZ-2661-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBard Access Systems, Inc., Salt Lake City, UT, United States
Recall initiated2026-05-21
Classified2026-07-02
Reported by FDA2026-07-08
DistributedNationwide (US)
Countries outside the USBE
Quantity915
UPC / GTIN / UDI-DI00801741107177, 00801741107184, 00801741107191, 00801741107214, 00801741107221
Lot numbers5855300, 5865120, 5865200, 5865240, REJZ0927, REKY1364, REKY1381, REKY2412, RELN0881

Product

5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 5865120 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107191 5865200 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI_DI Code: 00801741107214 5865240 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107221 The Power-Trialysis Slim-Cath Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Reason for recall

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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-2661-2026. 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.