PowerLoc MAX Power Injectable Infusion Set with GuardIVa… — Class II medical device recall Z-2663-2020
Terminated recall by Becton Dickinson & Company, reported 2020-07-29. Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that ha
| Recall number | Z-2663-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2020-06-19 |
| Classified | 2020-07-18 |
| Reported by FDA | 2020-07-29 |
| Terminated | 2022-07-29 |
| Quantity | 5,296,132 total |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00801741085680, 00801741095504, 00801741095511, 00801741095542 |
| Lot numbers | REDW1093, REDW2530, REDX0120, REDX0188, REDX1388, REDY0771, REDY0772, REDY2980, REEN1111, REEN1112, REEN2070, REEN2779, REEN4550, REEP0993, REEP2910, REEQ4095, REER0529, REER2358 |
| Model numbers | 2132010G |
Product
PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI 00801741095542), 2142010G (UDI 00801741085680), 2142015G (UDI 00801741085680), 2142210G (UDI 00801741085680)
Reason for recall
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
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-2663-2020. 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.