Medical Device Recall: Z-0001-2022

FDA Recalls dataset · Firm: Potomac River Group, Corp. · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2021-04-21 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0001-2022.

Recall Res Number
Z-0001-2022
Recalling Firm / Manufacturer
Potomac River Group, Corp.
FEI Number
3004918946
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2021-04-21
Date Posted
N/A
Date Terminated
N/A
Product Code
REP
Event Number
88735
Product Quantity
62 units
Product Description RAPTAR Laser Range Finders
Reason for Recall RAPTAR units are capable of being field modified to enable the use of the higher power visible and IR laser pointers and the IR Illuminator.
Action Details Potomac River Group (PRG) sent communications to the purchasers of the affected units that were locked in the eye safe mode and distributed without the keys. PRG expects to offer all affected purchasers at least a refund option. PRG s ability to offer a repair option is contingent upon assistance from Wilcox, which is the only entity PRG is aware of that has the ability to render the units compliant with FDA specifications.
Distribution Pattern US Nationwide
Code Information / Serial Numbers RAPTAR G02 (Wilcox Part #57200G02)

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