Stryker Visum 300 Ceiling-mounted Exam Light.
This recall has been terminated (originally issued August 21, 2013).
- Company
- Stryker Communications
- Recall Initiated
- July 25, 2013
- Posted
- August 21, 2013
- Terminated
- April 3, 2015
- Recall Number
- Z-1992-2013
- Quantity
- 1,375 units
- Firm Location
- Flower Mound, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Potential incomplete final weld on the drop tube flange.
Distribution
Worldwide Distribution: US natiowide and to the country of Canada.
Lot / Code Info
Product sold under the following part numbers: 0682001410A, 0682001410B, 0682001410C, 0682001410D, 0682001410E, 0682001410F, 0682001410G, and 0682001410H and shipped prior to February 28, 2013.
Root Cause
Process control
Action Taken
The firm decided to recall and notified consignees with an "Urgent Medical Device Correction/Removal" notification letter dated 07/29/13. The product issue was described and recommended actions were provided. Customers may contact Stryker Technical Support at 866-841-5663.
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