FDA recall Z-2423-2021

Product

Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy

Reason for recall

Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2021-08-03

Report date

2021-09-15

Termination date

2023-01-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2423-2021