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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion

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 Class 2 Device Recall Centurionsee related information
Date Initiated by FirmApril 24, 2019
Create DateOctober 09, 2019
Recall Status1 Terminated 3 on April 03, 2020
Recall NumberZ-0088-2020
Recall Event ID 83584
510(K)NumberK171957 
Product Classification Cardiac catheterization kit - Product Code OES
ProductTRIPLE LUMEN BUNDLE KIT ECVC1540
Code Information 2017102650 2018010550 2018020850 2018042650 2018071650 2018081050 2018090450 2018100950 2018101750 2019032250 
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
For Additional Information ContactLisa A. Carpenter
517-546-3356
Manufacturer Reason
for Recall		Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn April 24, 2019, the firm notified customers who had received kits containing BD's MaxZero product. Customers were instructed to do the following: 1. Whether or not you have product in inventory, please complete and return the attached Centurion Accountability Record via email- lcarpenter@centurionmp.com or via fax-517-546-3356. 2. Please share this communication with all users of the product within your organization, as directed in the BD letter. 3. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program. Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1- 800-332-1088); Mail: MedWatch, HF-2, FDA, 5600 Fisher's Lane, Rockville, MD 20852- 9787
Quantity in Commerce181965 total
DistributionNationwide domestic distribution.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = OES
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