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U.S. Department of Health and Human Services

Class 1 Device Recall Recirculator 8.0s Disposable Lavage Kit

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 Class 1 Device Recall Recirculator 8.0s Disposable Lavage Kitsee related information
Date Initiated by FirmJune 04, 2021
Create DateJuly 23, 2021
Recall Status1 Terminated 3 on August 03, 2023
Recall NumberZ-2005-2021
Recall Event ID 87406
510(K)NumberK102900 
Product Classification Warmer, thermal, infusion fluid - Product Code LGZ
ProductRecirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.
Code Information UDI: 08719992086016  Lot Numbers: 20021361 20202106 20202106 20018480 19854186 20019438 20018480 19854186 19854185 20202106 20019438 19854184 20202106 20018480 20202106 20018480 18687686
Recalling Firm/
Manufacturer		 Eight Medical International BV
Laan Van Hildernisse-Noord 2a
Bergen Op Zoom Netherlands
Manufacturer Reason
for Recall		The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
FDA Determined
Cause 2		Device Design
ActionAn Urgent: Medical Device Recall notification letter dated 6/7/21 was emailed and mailed to customers. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: Inspect inventory and quarantine impacted product. Remove and destroy the instruction for use (IFU) (Rev F) upon opening the kit during the treatment Replace with the IFU (Rev G)  attached to this letter Attach the laminated card provided with this letter on the fluid warmer device itself, not on the disposable kit. Until we are able to provide kits with the corrected IFU (Rev G), please continue to use the attached Rev G. Complete and return response form FM-018-02 via email to hurtt.tracy@eightmedical.com (the document is attached) TYPE OF ACTION BY THE COMPANY: EIGHT MEDICAL INTERNATIONAL B.V. is working towards an updated design solution and will notify customers in order to replace products, when available. OTHER INFORMATION: If you need any further information or support concerning this issue, please contact Tracy Hurtt, hurtt.tracy@eightmedical.com For calls +1 (812) 212-2198 - Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. For Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in Commerce22
DistributionUS Nationwide, Colombia, and Dubai.
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 = LGZ
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