Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 22, 2023
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
Fenwal Inc recalled Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis… - a moderate-severity action.
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis… was recalled by Fenwal Inc in March 22, 2023. Reason: Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amic…. Check the official notice for the remedy. Verify recall #Z-1255-2023 with the FDA Devices before acting.
The recall
Fenwal Inc issued this moderate-severity FDA Devices recall-Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amic….
- Moderate
- severity level
- 7K units
- affected scope
- Class II
- classification
- March 22, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1255-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1255-2023) was formally reported on March 22, 2023, with the manufacturer initiating the action on February 14, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Fenwal Inc is listed as the recalling firm, operating out of Lake Zurich, IL. Federal records list the affected scope as 6,564 units.
The documented reason for this recall is: Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator. Distribution data in the federal record shows the product reached: Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.. 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
6,564 units
Related Recalls
6
3 from same agency
Product description
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Reason for recall
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1255-2023 |
| Date reported | March 22, 2023 |
| Date initiated | February 14, 2023 |
| Recalling firm | Fenwal Inc |
| Firm location | Lake Zurich, IL |
| Affected scope | 6,564 units |
| Distribution | Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada. |
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-1255-2023) 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? ▼
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform. Recalled by Fenwal Inc. Units affected: 6,564 units.
Why was this product recalled? ▼
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 22, 2023. Severity: Moderate. Recall number: Z-1255-2023.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1255-2023) 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 March 22, 2023. 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.