Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1569-2009

Amico E-Cylinder Canister Holder, distributed by Stryker Communications, Flower Mound, TX 75028. Canister...

STRYKER Communications, Inc. / initiated 2009-05-19 / Terminated / root cause: design

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.