Amico E-Cylinder Canister Holder, distributed by Stryker Communications, Flower Mound, TX 75028. Canister...
Stryker Communications Corp began a recall of Amico E-Cylinder Canister Holder, distributed by Stryker Communications, Flower Mound, TX 75028. Canister holder is used to hang E-Cylinders (pressurized gas... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1569-2009
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- STRYKER Communications, Inc.
- Product
- 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.
- Product code
- BRY Cabinet, Table And Tray, Anesthesia
- 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.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- 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.
- Quantity in commerce
- 66 units.
- Distribution
- Nationwide and Canada.
- Product codes and lots
- Catalog/Product Number: 0682-001-111 and 0682-000-449. All E-Cylinder canister holders shipped between 01 JAN 05 and 27 SEP 06.
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