FDA Device recall Z-2663-2020
PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit
- FDA Device
- Class II
- terminated
- Published 2020-07-29
On 2020-07-29 the FDA classified a Class II recall of PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit by Becton Dickinson And, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2663-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-19 |
| Published | 2020-07-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Becton Dickinson And |
| Distribution | n/a |
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
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.
Identifiers
| code_info | Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI 00801741095542), 2142010G (…Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI 00801741095542), 2142010G (UDI 00801741085680), 2142015G (UDI 00801741085680), 2142210G (UDI 00801741085680). Lot Numbers: REDY0771 REDY2980 REEN1111 REEN4550 REER0529 REEN2070 REEP0993 REDX0120 REDW1093 REDW2530 REDX1388 REDY0772 REEN1112 REEN2779 REEP2910 REEQ4095 REER2358 REDX0188 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2663-2020%22
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