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FDA Medical Device Recalls (openFDA)

Centurion Medical Products Corporation: Centurion-Suture Tray DYNDR1210A SUTURING TRAY

Recall number
Z-1075-2020
Recalling firm
Centurion Medical Products Corporation
Product
Centurion-Suture Tray DYNDR1210A SUTURING TRAY
Status
Terminated
Initiated
2019-12-11
Posted
not on file
Terminated
2020-09-04
Reason
Incomplete seals on the sterile package may compromise the sterility
Root cause
Packaging process control
Action
Centurion issued a notification emailed to Medline Industries, Centurion's parent company. Centurion issued mailing letters via First Class Mail beginning on 12/12/2019, letter states reason for recall, health risk and action to take: Please identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use. 2) If you have transferred possession of this product to another individual, to another department or to another location in your organization, you are required by FDA regulations to notify them of this recall communication. Please ask that any affected product be returned to you for collection. 3) Affected product is not to be returned to Centurion, and should be destroyed/discarded. Document the destruction of all product on the enclosed accountability record. 4) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter, Director of Quality Assurance Centurion Medical Products Corporation, (517) 546-5400 Ext.1122.
Quantity
not on file
Distribution
Nationwide Foreign: GHANA
Lot, serial or model codes
Product-Lot Code: DYNDR1210A SUTURING TRAY 2019031290
510(k) numbers
not on file
PMA numbers
not on file
Product code
LRP
Firm FEI
3008403546
Firm city
Williamston
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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