Z-0105-2010

Tri-State Hospital Supply Corp., Centurion Healthcare Products Premie Packs, 50, sterile, Tri-State Hospital...

Name: Z-0105-2010 Tri-State Hospital Supply Corp., Centurion Healthcare Products Premie Packs, 50, sterile, Tri-State Hospital...
Creator: Centurion Medical Products
Published: 2009-09-22
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2009-09-22 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products began a recall of Tri-State Hospital Supply Corp., Centurion Healthcare Products Premie Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM110... on 2009-09-22. The reason FDA records is "The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated in the label, which could result in an inability to remove secretions and cause partial or complete...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0105-2010
Status: Terminated
Initiated: 2009-09-22
Posted: 2009-11-12
Terminated: 2010-08-03
Recalling firm: Centurion Medical Products, LP
Product: Tri-State Hospital Supply Corp., Centurion Healthcare Products Premie Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM110. Aspiration tray containing Portex uncuffed pediatric sized tracheal tubes.
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated in the label, which could result in an inability to remove secretions and cause partial or complete obstruction of the airway.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm's sales representative was notified of the recall on September 22, 2009 via email and the sole customer was notified by letter dated September 23, 2009. All product was removed from the customer account on September 28, 2009 and returned to the recalling firm.
Quantity in commerce: 650
Distribution: Illinois.
Product codes and lots: Lots 901087, 903267, 907307, 910297, 901218, 908258, 2009020990 and 2009022390.

Product code BTR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)