Z-1595-2010

Basic Core Pack # OR1805, Sterile, Tri State Hospital Supply Corporation Manufacturers of Centurion...

Name: Z-1595-2010 Basic Core Pack # OR1805, Sterile, Tri State Hospital Supply Corporation Manufacturers of Centurion...
Creator: Centurion Medical Products
Published: 2010-04-09
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2010-04-09 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products began a recall of Basic Core Pack # OR1805, Sterile, Tri State Hospital Supply Corporation Manufacturers of Centurion Healthcare Products on 2010-04-09. The reason FDA records is "The firm is conducting a sub recall of kits containing ConMed Goldline Rocker Switch Pencils. The pencils activation switch may remain in the "on" position after the switch has been depressed with excessive force...". 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-1595-2010
Status: Terminated
Initiated: 2010-04-09
Posted: 2010-05-12
Terminated: 2010-10-25
Recalling firm: Centurion Medical Products, LP
Product: Basic Core Pack # OR1805, Sterile, Tri State Hospital Supply Corporation Manufacturers of Centurion Healthcare Products.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The firm is conducting a sub recall of kits containing ConMed Goldline Rocker Switch Pencils. The pencils activation switch may remain in the "on" position after the switch has been depressed with excessive force, thereby continuously activating the pencil.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Centurion sent out an "Urgent Product Recall Notice" to one customer on 4/9/2010. The customer was instructed to discontinue use of the product. The customer was also instructed to return any instock product .
Quantity in commerce: 74 kits
Distribution: TX
Product codes and lots: 2009100590, 2009110990, 2009121490, 2010011190 and 2010031590.

Product code GEI

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)