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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion_General Surgery Trays

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  Class 2 Device Recall Centurion_General Surgery Trays 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-1048-2020
Recall Event ID 84530
Product Classification Tray, surgical - Product Code LRP
Product Centurion-_General Surgery Trays
DYNDA1127A RADIOLOGY CUT DOWN TRAY #1
DYNDA1178 ICIO TRAY
DYNDA1183 AUXILARY TOWEL PACK
DYNDA1223 CUSTOM PREP CUP KIT
DYNDA1223 CUSTOM PREP CUP KIT
DYNDA1246A CIRCUMCISION PACK
DYNDA1349A CIRCUMCISION TRAY
DYNDA1388 STERILE EK DOUBLE PACK
DYNDA1615 STERILE BARRIER KIT
DYNDA1615 STERILE BARRIER KIT
DYNDA1628 VAG DELIVERY ACCESSORY PACK
DYNDA1706A CIRCUMCISION TRAY W/OUT CLAMP
DYNDA1843A DISPOSABLE SUTURE TRAY FGS
DYNDA1843A DISPOSABLE SUTURE TRAY FGS
DYNDA1861 IR KIT
DYNDA1904 PREP TRAY
DYNDA2076 VEIN PROCEDURE KIT
DYNDA2201 SMALL BOWL KIT
DYNDA2241 CIRCUMCISION TRAY
DYNDA2271 CIRCUMCISION TRAY
DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER
DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER
DYNDA2418 MINOR PROCEDURE TRAY
DYNDA2498 STERILE UNIVERSAL KIT
Code Information Lot Numbers:  DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 2019031990 DYNDA1178 ICIO TRAY 2019050690 DYNDA1183 AUXILARY TOWEL PACK 2018100390 DYNDA1223 CUSTOM PREP CUP KIT 2019031290 DYNDA1223 CUSTOM PREP CUP KIT 2019021490 DYNDA1246A CIRCUMCISION PACK 2018111290 DYNDA1349A CIRCUMCISION TRAY 2019030190 DYNDA1388 STERILE EK DOUBLE PACK 2019030890 DYNDA1615 STERILE BARRIER KIT 2019031590 DYNDA1615 STERILE BARRIER KIT 2019012390 DYNDA1628 VAG DELIVERY ACCESSORY PACK 2019040290 DYNDA1706A CIRCUMCISION TRAY W/OUT CLAMP 2019031290 DYNDA1843A DISPOSABLE SUTURE TRAY FGS 2019061090 DYNDA1843A DISPOSABLE SUTURE TRAY FGS 2019030190 DYNDA1861 IR KIT 2019022590 DYNDA1904 PREP TRAY 2019011590 DYNDA2076 VEIN PROCEDURE KIT 2018101590 DYNDA2201 SMALL BOWL KIT 2019022690 DYNDA2241 CIRCUMCISION TRAY 2019032590 DYNDA2271 CIRCUMCISION TRAY 2019031990 DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER 2019050690 DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER 2019030590 DYNDA2418 MINOR PROCEDURE TRAY 2019021390 DYNDA2498 STERILE UNIVERSAL KIT 2019061190 
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.
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