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U.S. Department of Health and Human Services

Class 2 Device Recall CareFusion SafeTCentesis Catheter Drainage Tray

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 Class 2 Device Recall CareFusion SafeTCentesis Catheter Drainage Traysee related information
Date Initiated by FirmMarch 26, 2020
Create DateApril 24, 2020
Recall Status1 Terminated 3 on August 21, 2020
Recall NumberZ-1795-2020
Recall Event ID 85380
Product Classification Needle, catheter - Product Code GCB
ProductCareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986
Code Information Lot Number: 0001304986
FEI Number 2243072
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactMs. Gail Griffiths
410-316-4054
Manufacturer Reason
for Recall		The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionOn March 26, 2020, an Urgent Medical Device Recall Notification was sent to consignees stating that Lot #0001304986 of the Safe-T-Centesis 8 Fr Catheter Drainage Trays shipped between June 27, 2019 and September 6, 2019 should be discarded. In addition, they were instructed to complete the Customer Response form regardless of whether or not they have any of the product. Customers with discarded product were instructed to indicate the number of affected products that were discarded on the response form and replacements would be issued to those customers.
Quantity in Commerce900
DistributionDomestic distribution to the following states: Alabama, Colorado, Illinois, Massachusetts, Missouri, Oklahoma, Rhode Island, Virginia, and Wisconsin.
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.
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