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Class 2 Device Recall Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 14 cm, LAV, Expanded Kit |
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Date Initiated by Firm |
January 02, 2020 |
Create Date |
May 14, 2020 |
Recall Status1 |
Terminated 3 on September 14, 2022 |
Recall Number |
Z-2000-2020 |
Recall Event ID |
85361 |
510(K)Number |
K091268
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Product Classification |
Catheter, oximeter, fiber-optic - Product Code DQE
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Product |
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41411-25
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Code Information |
LOT Number/ UDI-4192314/1 0840619 04645 0 |
Recalling Firm/ Manufacturer |
ICU Medical, Inc. 951 Calle Amanecer San Clemente CA 92673-6212
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For Additional Information Contact |
ICU Medical, Inc. 844-654-7780
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Manufacturer Reason for Recall |
Inability for the guidewire to pass through the needles included with the catheter kits.
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FDA Determined Cause 2 |
Process control |
Action |
The firm has contracted Stericycle, Inc., Indianapolis, IN for customer notification, response tracking and effectiveness check.
On 02 January 2020, Stericycle, Inc. sent URGENT: MEDICAL DEVICE RECALL notification of the market action to the firm's direct consignees of record. |
Quantity in Commerce |
10 |
Distribution |
US Consignees including in the states of AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA and WA
OUS - Canada. |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = DQE and Original Applicant = HOSPIRA, INC.
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