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Terminated

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

FDA Recall Z-1595-2010 · Posted 2010-05-12

Recalling FirmCenturion Medical Products
Recall StatusTerminated
Product CodeGEI
Date Initiated2010-04-09
Date Terminated2010-10-25
Product Quantity74 kits

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.

Firm 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 .

Root Cause

Nonconforming Material/Component

Distribution Pattern

TX

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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