Z-1992-2013 Class II Terminated
FDA device recall Z-1992-2013 was initiated by Stryker Communications on July 25, 2013 and is designated Class II. Reason for recall: Potential incomplete final weld on the drop tube flange. The recall status is terminated (terminated April 3, 2015). Affected quantity: 1,375 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2013
- Initiation Date
- July 25, 2013
- Termination Date
- April 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,375 units
Product Description
Stryker Visum 300 Ceiling-mounted Exam Light.
Reason for Recall
Potential incomplete final weld on the drop tube flange.
Distribution Pattern
Worldwide Distribution: US natiowide and to the country of Canada.
Code Information
Product sold under the following part numbers: 0682001410A, 0682001410B, 0682001410C, 0682001410D, 0682001410E, 0682001410F, 0682001410G, and 0682001410H and shipped prior to February 28, 2013.