Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0484-2012

Raymond Laser alignment guide - Model #1096597/001 Green Laser. Intended to assist operators in performing...

The Raymond Corporation / initiated 2011-11-28 / Terminated / root cause: labeling and UDI

The Raymond Corporation began a recall of Raymond Laser alignment guide - Model #1096597/001 Green Laser. Intended to assist operators in performing material handling activities such as storing and... on . The reason FDA records is "Raymond shipped a laser alignment guide as an option on its powered industrial trucks from February 2, 2010 through April 21, 2011, but was not aware of its obligation under 21 C.F.R. 1010.2 and 1010.3 to certify and...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0484-2012
Status
Terminated
Initiated
Posted
Recalling firm
The Raymond Corporation
Product
Raymond Laser alignment guide - Model #1096597/001 Green Laser. Intended to assist operators in performing material handling activities such as storing and retrieving pallets and material in and on racking projecting a line onto a pallet or other material storage medium for assisting the operator in determining the position of the powered industrial truck forks with respect to load.
Product code
RER Alignment Laser Product
Reason for recall
Raymond shipped a laser alignment guide as an option on its powered industrial trucks from February 2, 2010 through April 21, 2011, but was not aware of its obligation under 21 C.F.R. 1010.2 and 1010.3 to certify and label.
Root cause tag
labeling and UDI
FDA root cause
Radiation Control for Health and Safety Act
Action
Raymond will be initiating a Field Campaign to ensure that all customers with Alignment Guides have the confirmatory laser caution decals and manufacturer label, an updated installation and service manual, the operator instructions, and informational brochure. This campaign will be performed at no cost to Raymond's dealers and customers, and will include documenting the laser serial number for each truck configured with an Alignment Guide for product traceability.
Quantity in commerce
493 total
Distribution
Nationwide Distribution
Product codes and lots
Model #1096597/001