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.
FDA Recall Z-1569-2009 · Posted 2009-07-13
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Recalling FirmStryker Communications Corp
Recall StatusTerminated
Product CodeBRY
Date Initiated2009-05-19
Date Terminated2010-04-26
Product Quantity66 units.
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide and Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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