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

FDA device recall Z-1569-2009 · posted 2009-07-13 · Terminated

Recall details

Recalling firm

Stryker Communications Corp

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.

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.

Root cause

Device Design

Status

Terminated

Product code

BRY

Quantity affected

66 units.

Distribution

Nationwide and Canada.

Date initiated

2009-05-19

Date posted

2009-07-13

Date terminated

2010-04-26

Location

Flower Mound, TX