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Class 2 Device Recall IV Adminstration Sets with ChemLock Ports |
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Date Initiated by Firm |
February 25, 2016 |
Create Date |
October 11, 2018 |
Recall Status1 |
Terminated 3 on August 26, 2016 |
Recall Number |
Z-1258-2016 |
Recall Event ID |
73391 |
510(K)Number |
K131549
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Product Classification |
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System - Product Code ONB
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Product |
30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clerestories devices intended for the infusion and withdrawal of fluids. |
Code Information |
2603990 2638178 2648080 2650789 2651575 2707143 2758814 2775922 2807999 2812304 2822505 2935268 2959788 2981443 2996455 3004510 3004872 3014970 3021774 3031244 3036751 3042661 3050748 3062734 3066394 3070408 3090587 3093069 3095818 3099253 3104787 3106886 3113237 3116568 3124603 3128411 3150731 3160102 3168416 3175643 3179949 3184510 |
Recalling Firm/ Manufacturer |
ICU Medical, Inc. 951 Calle Amanecer San Clemente CA 92673-6212
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For Additional Information Contact |
949-366-2183
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Manufacturer Reason for Recall |
ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
A customer notification letter dated 2/25/16 was sent to all customers who purchased the IV Administration Sets with ChemoLock Port to inform them that ICU Medical has identified an issue with a connection in an isolated number of I.V. Infusion administration sets that incorporate the ChemoLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak. Customers are informed of the actions to be taken. Customers are instructed to return and complete the recall response form to ICU Medical via Fax (801) 264-1755 or by email: recall@icumed.com. Customers with questions or require assistance relating to the recall are instructed to contact Customer Service Monday through Friday between the hours of 8:30AM-4:00PM Pacific Time, (866) 829-9025 and select option 8, or email at customerservice@icumed.com. |
Quantity in Commerce |
19,250 units |
Distribution |
US: NV, OH, MO, CA, FL, VA, TX, NJ, CT, MI, AZ, MA, CO
Non-US: DE, AE, AT, PL, HU, SE, IL, JP, JO, SA, |
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 = ONB and Original Applicant = ICU MEDICAL INC
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