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U.S. Department of Health and Human Services

Class 2 Device Recall Chemetron

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  Class 2 Device Recall Chemetron see related information
Date Initiated by Firm May 15, 2009
Date Posted September 10, 2009
Recall Status1 Terminated 3 on April 23, 2012
Recall Number Z-2031-2009
Recall Event ID 52383
Product Classification compressed gas cylinder and valve - Product Code ECX
Product Empty M9 aluminum oxygen cylinders packaged in shipping containers (1 per container) labeled as: Product #0022-57P, Desc: CYL 02 ALUM 240 LITER, Catalog #31-10-2012. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.
Code Information InterMed 08-05-3B and InterMed 09-01-1B located on the post valve.
Recalling Firm/
Manufacturer		 Allied Healthcare Products Inc
1720 Sublette Ave
St. Louis MO 63110
For Additional Information Contact Stephen Mundwiller
314-771-2400
Manufacturer Reason
for Recall		 Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recalling firm first notified their customers via a letter dated 5/15/09 issued regular mail explaining the reason for recall and requesting the cylinders with specific post valves be returned. A second letter dated 6/1/09 was issued via regular mail which provided specific shipping dates that each customer received the suspect product. Neither of these two letters requested subrecall. A third letter dated 6/17/09, which included copies of the first two letters, via certified mail. This letter informed the customer the recall was to be conducted to the user level and requested their customer conduct a subrecall. Requested to remove the cylinder from service and call Allied Healthcare Products for return and a replacement at 1-800-268-1661.
Quantity in Commerce 10 cylinders
Distribution Class II Recall Worldwide Distribution including states of NY, NC, KY, PA, WI, NH, NJ, CA, CT, FL and Singapore.
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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