PlainRecordsFDA · Medical device recall
Guardian Walker… and 1 more product
- Date posted by the FDA
- Aug. 24, 2006
- Status
- Terminated
- Filed by
- A & E Industries, Ltd.
- Reason
- Walker wheel hubs may fracture, causing walker to collapse to one side.
- Distribution pattern
- Worldwide distribution --- USA and countries of Bangladesh, Chile, Japan, and Mexico
2 products in this recall
Guardian Walker…
- Product
- Guardian Walker, Models 30751W, 30757W, 30758W, Made in China by A&E Machinery Industry Co., Ltd.
- Quantity
- 32,636 units.
- Codes and lots
- Models 30751W, 30757W, 30758W. Lots 0603, 0604, 0605.
- Recall started
- June 30, 2006
- Device type
- Walker, Mechanical
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by letter on 06/30/2006.
- Recall number
- Z-1420-06
Guardian 5 inch Walker Wheel Kits…
- Product
- Guardian 5 inch Walker Wheel Kits, Model Numbers: 07722-8, 07722G, 07722-5, 07722-8B, 07725. Made in China by A&E Machinery Industry Co., Ltd.
- Quantity
- 63,153 units.
- Codes and lots
- Model numbers 07722-8, 07722G, 07722-5, 07722-8B, 07725. Lot numbers 0603, 0604, 0605.
- Recall started
- June 30, 2006
- Device type
- Walker, Mechanical
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by letter on 06/30/2006.
- Recall number
- Z-1421-06
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1420-06, Z-1421-06. The agency record governs; check it and the company before acting.