Raymond Laser alignment guide - Model #1096597/002 Red Laser. Intended to assist operators in performing...
The Raymond Corporation began a recall of Raymond Laser alignment guide - Model #1096597/002 Red 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-0485-2012
- Status
- Terminated
- Initiated
- Posted
- Recalling firm
- The Raymond Corporation
- Product
- Raymond Laser alignment guide - Model #1096597/002 Red 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 #1096597/002
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
