Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 9, 2018
Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operatively within patient suites. The collection containers hold the fluids until they are ready for
products may be missing a one-way valve on the fluid patient port.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cardinal Health 200, LLC recalled Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-91… - a moderate-severity action.
Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-91… was recalled by Cardinal Health 200, LLC in May 9, 2018. Reason: products may be missing a one-way valve on the fluid patient port.. Check the official notice for the remedy. Verify recall #Z-1546-2018 with the FDA Devices before acting.
The recall
Cardinal Health 200, LLC issued this moderate-severity FDA Devices recall-products may be missing a one-way valve on the fluid patient port..
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- May 9, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1546-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1546-2018) was formally reported on May 9, 2018, with the manufacturer initiating the action on March 28, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Cardinal Health 200, LLC is listed as the recalling firm, operating out of Waukegan, IL. Federal records list the affected scope as 3600 units.
The documented reason for this recall is: products may be missing a one-way valve on the fluid patient port. Distribution data in the federal record shows the product reached: US Distribution to the state of MA. 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
3600 units
Related Recalls
6
3 from same agency
Product description
Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operatively within patient suites. The collection containers hold the fluids until they are ready for proper disposal. Sources of vacuum range from wall suction (central vacuum piped throughout the healthcare facility) to liposuction devices (portable suction pumps).
Reason for recall
products may be missing a one-way valve on the fluid patient port.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1546-2018 |
| Date reported | May 9, 2018 |
| Date initiated | March 28, 2018 |
| Recalling firm | Cardinal Health 200, LLC |
| Firm location | Waukegan, IL |
| Affected scope | 3600 units |
| Distribution | US Distribution to the state of MA |
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-1546-2018) 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? ▼
Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operatively within patient suites. The collection containers hold the fluids until they are ready for proper disposal. Sources of vacuum range from wall suction (central vacuum piped throughout the healthcare facility) to liposuction devices (portable suction pumps).. Recalled by Cardinal Health 200, LLC. Units affected: 3600 units.
Why was this product recalled? ▼
products may be missing a one-way valve on the fluid patient port.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 9, 2018. Severity: Moderate. Recall number: Z-1546-2018.
Where was the recalled product distributed? ▼
Distribution: US Distribution to the state of MA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1546-2018) 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 May 9, 2018. 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.