Empty M9 aluminum oxygen cylinders packaged in shipping containers (1 per container) labeled as: Product #0022-57P, Desc

FDA device recall Z-2031-2009 · posted 2009-09-10 · Terminated

Recall details

Recalling firm

Allied Healthcare Products Inc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

ECX

Quantity affected

10 cylinders

Distribution

Class II Recall Worldwide Distribution including states of NY, NC, KY, PA, WI, NH, NJ, CA, CT, FL and Singapore.

Date initiated

2009-05-15

Date posted

2009-09-10

Date terminated

2012-04-23

Location

St. Louis, MO