Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Centurion Dressing Tray

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Centurion Dressing Tray see related information
Date Initiated by Firm December 11, 2019
Create Date February 05, 2020
Recall Status1 Terminated 3 on September 04, 2020
Recall Number Z-1087-2020
Recall Event ID 84530
Product Classification Dressing change tray - Product Code OXQ
Product Centurion- Dressing Tray
M101156A DRESSING TRAY
M101167A DRESSING TRAY
M101168A DRESSING TRAY
M101170A MAJOR DRESSING TRAY
M101170A MAJOR DRESSING TRAY
M101170A MAJOR DRESSING TRAY
M101170A MAJOR DRESSING TRAY
M101172B MINOR CORE DRESSING TRAY
M101172B MINOR CORE DRESSING TRAY
M101172B MINOR CORE DRESSING TRAY
M101358 LACERATION TRAY
M101358 LACERATION TRAY
M101358 LACERATION TRAY
M101413 ADULT LUMBAR PUMP W NDLS MANO
M101472A PREP PACK
Code Information Product/Lot Code:  M101156A DRESSING TRAY 2019041690 M101167A DRESSING TRAY 2018122190 M101168A DRESSING TRAY 2018122890 M101170A MAJOR DRESSING TRAY 2019040490 M101170A MAJOR DRESSING TRAY 2019021290 M101170A MAJOR DRESSING TRAY 2019020890 M101170A MAJOR DRESSING TRAY 2019012390 M101172B MINOR CORE DRESSING TRAY 2019041290 M101172B MINOR CORE DRESSING TRAY 2019030690 M101172B MINOR CORE DRESSING TRAY 2019020190 M101358 LACERATION TRAY 2019032290 M101358 LACERATION TRAY 2019021490 M101358 LACERATION TRAY 2019011890 M101413 ADULT LUMBAR PUMP W NDLS MANO 2019052190 M101472A PREP PACK 2019052990  
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
For Additional Information Contact SAME
517-546-5400
Manufacturer Reason
for Recall		 Incomplete seals on the sterile package may compromise the sterility
FDA Determined
Cause 2		 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.
Distribution Nationwide Foreign: GHANA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-