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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, 20 cm, MAP, Basic Kit

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  Class 2 Device Recall Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 20 cm, MAP, Basic Kit see related information
Date Initiated by Firm January 02, 2020
Create Date May 14, 2020
Recall Status1 Terminated 3 on September 14, 2022
Recall Number Z-1996-2020
Recall Event ID 85361
Product Classification Catheter, oximeter, fiber-optic - Product Code DQE
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. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4
Code Information LOT 4330832 UDI:1 0840619 04197 4
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact ICU 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
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 20
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
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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