Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported August 4, 2021
Recirculator 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.
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Eight Medical International Bv recalled Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016… - a critical-severity action.
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016… was recalled by Eight Medical International Bv in August 4, 2021. Reason: The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditi…. Check the official notice for the remedy. Verify recall #Z-2005-2021 with the FDA Devices before acting.
The recall
Eight Medical International Bv issued this critical-severity FDA Devices recall-The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditi….
- Critical
- severity level
- 22 units
- affected scope
- Class I
- classification
- August 4, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2005-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2005-2021) was formally reported on August 4, 2021, with the manufacturer initiating the action on June 4, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Eight Medical International Bv is listed as the recalling firm, operating out of Bergen Op Zoom, N/A. Federal records list the affected scope as 22.
The documented reason for this recall is: The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions. Distribution data in the federal record shows the product reached: US Nationwide, Colombia, and Dubai.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
22
Related Recalls
6
3 from same agency
Product description
Recirculator 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.
Reason for recall
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2005-2021 |
| Date reported | August 4, 2021 |
| Date initiated | June 4, 2021 |
| Recalling firm | Eight Medical International Bv |
| Firm location | Bergen Op Zoom, N/A |
| Affected scope | 22 |
| Distribution | US Nationwide, Colombia, and Dubai. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2005-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Recirculator 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.. Recalled by Eight Medical International Bv. Units affected: 22.
Why was this product recalled? ▼
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 4, 2021. Severity: Critical. Recall number: Z-2005-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide, Colombia, and Dubai..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2005-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 4, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.