FDA Medical Device Recalls (openFDA)
Allied Healthcare Products Inc: First Responder Kit containing a 240-liter aluminum oxygen cylinder with individually packaged regulator, cannula, and bag mask resuscitator, all packaged in a shipping container labeled as: Product #L903, Desc FIRST RESPONDER KIT, Catalog #L903. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.
- Recall number
- Z-2038-2009
- Recalling firm
- Allied Healthcare Products Inc
- Product
- First Responder Kit containing a 240-liter aluminum oxygen cylinder with individually packaged regulator, cannula, and bag mask resuscitator, all packaged in a shipping container labeled as: Product #L903, Desc FIRST RESPONDER KIT, Catalog #L903. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.
- Status
- Terminated
- Initiated
- 2009-05-15
- Posted
- 2009-09-10
- Terminated
- 2012-04-23
- Reason
- 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.
- Root cause
- 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
- 9 cylinders
- Distribution
- Class II Recall Worldwide Distribution including states of NY, NC, KY, PA, WI, NH, NJ, CA, CT, FL and Singapore.
- Lot, serial or model codes
- InterMed 08-05-3B and InterMed 09-01-1B located on the post valve.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ECX
- Firm FEI
- 1924066
- Firm city
- St. Louis
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28