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Class 2 Device Recall Universal Drainage Set |
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Date Initiated by Firm |
May 28, 2020 |
Create Date |
July 20, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2650-2020 |
Recall Event ID |
85751 |
Product Classification |
Thoracentesis tray - Product Code PXI
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Product |
Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray |
Code Information |
Catalog: PIG1260TSP UDI: 50885403108387; Batches: 0001319377, 0001321496, 0001324092, 0001333971, 0001335442, 0001336583, 0001336964, 0001338981, 0001343845, 0001344649, 0001346293 |
Recalling Firm/ Manufacturer |
Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845
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For Additional Information Contact |
BD Customer Support 888-237-2762
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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.
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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
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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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