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U.S. Department of Health and Human Services

Class 2 Device Recall Amico ECylinder Canister Holder

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  Class 2 Device Recall Amico ECylinder Canister Holder see related information
Date Initiated by Firm May 19, 2009
Date Posted July 13, 2009
Recall Status1 Terminated 3 on April 26, 2010
Recall Number Z-1569-2009
Recall Event ID 52099
Product Classification E-Cylinder Canister Holder - Product Code BRY
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.
Code Information Catalog/Product Number: 0682-001-111 and 0682-000-449.  All E-Cylinder canister holders shipped between 01 JAN 05 and 27 SEP 06.
Recalling Firm/
Manufacturer		 Stryker Communications Corp
1410 Lakeside Pkwy Ste 100
Flower Mound TX 75028-4026
For Additional Information Contact
972-410-7310
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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