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U.S. Department of Health and Human Services

Class 2 Device Recall Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 30 cm, PMAP, Expanded Kit

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 Class 2 Device Recall Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 30 cm, PMAP, Expanded Kitsee related information
Date Initiated by FirmJanuary 02, 2020
Create DateMay 14, 2020
Recall Status1 Terminated 3 on September 14, 2022
Recall NumberZ-2001-2020
Recall Event ID 85361
510(K)NumberK091268 
Product Classification Catheter, oximeter, fiber-optic - Product Code DQE
ProductCentral 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 # 41414-23
Code Information LOT Number/ UDI - 4156000/1 0840619 04647 4, 4174850/1 0840619 04647 4, 4192313/1 0840619 04647 4, 4330831/1 0840619 04647 4, 4365303/1 0840619 04647 4
FEI Number 2025816
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information ContactICU Medical, Inc.
844-654-7780
Manufacturer Reason
for Recall		Inability for the guidewire to pass through the needles included with the catheter kits.
FDA Determined
Cause 2		Process control
ActionThe 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 Commerce235
DistributionUS 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 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.
510(K) Database510(K)s with Product Code = DQE
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