Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 20, 2014
Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Gambro Renal Products, Incorporated recalled Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouche… - a moderate-severity action.
Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouche… was recalled by Gambro Renal Products, Incorporated in August 20, 2014. Reason: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in…. Check the official notice for the remedy. Verify recall #Z-2203-2014 with the FDA Devices before acting.
The recall
Gambro Renal Products, Incorporated issued this moderate-severity FDA Devices recall-Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in….
- Moderate
- severity level
- 401K units
- affected scope
- Class II
- classification
- August 20, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2203-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2203-2014) was formally reported on August 20, 2014, with the manufacturer initiating the action on July 18, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Gambro Renal Products, Incorporated is listed as the recalling firm, operating out of Lakewood, CO. Federal records list the affected scope as 401,451, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Distribution data in the federal record shows the product reached: Worldwide Distribution.. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
401,451
Related Recalls
6
3 from same agency
Product description
Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
Reason for recall
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2203-2014 |
| Date reported | August 20, 2014 |
| Date initiated | July 18, 2014 |
| Recalling firm | Gambro Renal Products, Incorporated |
| Firm location | Lakewood, CO |
| Affected scope | 401,451 |
| Distribution | Worldwide Distribution. |
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-2203-2014) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box. Recalled by Gambro Renal Products, Incorporated. Units affected: 401,451.
Why was this product recalled? ▼
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 20, 2014. Severity: Moderate. Recall number: Z-2203-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2203-2014) 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.
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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 20, 2014. 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.