Amico E-Cylinder Canister Holder, distributed by Stryker Communications, Flower Mound, TX 75028. Canister holder is used to hang E-Cylinders (pressurized gas canisters) from a boom. Product typically used in the surgical setting.
This recall has been terminated (originally issued July 13, 2009).
- Company
- Stryker Communications Corp
- Recall Initiated
- May 19, 2009
- Posted
- July 13, 2009
- Terminated
- April 26, 2010
- Recall Number
- Z-1569-2009
- Quantity
- 66 units.
- Firm Location
- Flower Mound, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Design flaw on the E-Cylinder canister holder may result in early fatigue and failure of the bracket screws, which could cause the cage to become detached from its mount and fall.
Distribution
Nationwide and Canada.
Lot / Code Info
Catalog/Product Number: 0682-001-111 and 0682-000-449. All E-Cylinder canister holders shipped between 01 JAN 05 and 27 SEP 06.
Root Cause
Device Design
Action Taken
An "Urgent: Device Recall" letter dated May 19, 2009 was issued to customers. Customers were advised to discontinue use of all affected E-cylinder holders. Consignees were asked to return the "Product Accountability Form" included with the recall letter, after which consignees will be provided with an improved cylinder holder at no cost. Direct questions to Stryker Communications at 1-972-410-7100.