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U.S. Department of Health and Human Services

Class 2 Device Recall Universal Drainage Set

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 Class 2 Device Recall Universal Drainage Setsee related information
Date Initiated by FirmMay 28, 2020
Create DateJuly 20, 2020
Recall Status1 Terminated 3 on September 20, 2024
Recall NumberZ-2659-2020
Recall Event ID 85751
Product Classification Thoracentesis tray - Product Code PXI
ProductSafe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray
Code Information Catalog: TPT1005SP UDI: 50885403220867; Batch: 0001345010 
FEI Number 3008002452
Recalling Firm/
Manufacturer		 Carefusion 2200 Inc
75 N Fairway Dr
Vernon Hills IL 60061-1845
For Additional Information ContactBD Customer Support
888-237-2762
Manufacturer Reason
for Recall		The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
FDA Determined
Cause 2		Under Investigation by firm
ActionAll affected consignees are being notified via FedEx mailed letter and/or email beginning 6/15/2020. BD requests a sub-recall to be conducted if product has been further distributed. Consignees are asked to complete the acknowledgement form included with the notification letter and return to BD.
Distribution370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.
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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