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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 Set see related information
Date Initiated by Firm May 28, 2020
Create Date July 20, 2020
Recall Status1 Open3, Classified
Recall Number Z-2649-2020
Recall Event ID 85751
Product Classification Thoracentesis tray - Product Code PXI
Product Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
Code Information Catalog: PIG1260TCDF UDI: 50885403231894; Batches 0001335833 and 0001341627 
Recalling Firm/
Manufacturer		 Carefusion 2200 Inc
75 N Fairway Dr
Vernon Hills IL 60061-1845
For Additional Information Contact BD 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
Action All 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.
Distribution 370 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 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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