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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-1595-2010
Recalling firm
Centurion Medical Products
Product
Basic Core Pack # OR1805, Sterile, Tri State Hospital Supply Corporation Manufacturers of Centurion Healthcare Products.
Status
Terminated
Initiated
2010-04-09
Posted
2010-05-12
Terminated
2010-10-25
Reason
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
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
74 kits
Distribution
TX
Lot, serial or model codes
2009100590, 2009110990, 2009121490, 2010011190 and 2010031590.
510(k) numbers
not on file
PMA numbers
not on file
Product code
GEI
Firm FEI
1824619
Firm city
Howell
Firm state
MI
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

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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

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