Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 10, 2020
Pressure Monitoring Set, C-PMS, G02838
The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cook Inc. recalled Pressure Monitoring Set, C-PMS, G02838 - a moderate-severity action.
Pressure Monitoring Set, C-PMS, G02838 was recalled by Cook Inc. in June 10, 2020. Reason: The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of th…. Check the official notice for the remedy. Verify recall #Z-2203-2020 with the FDA Devices before acting.
The recall
Cook Inc. issued this moderate-severity FDA Devices recall-The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of th….
- Moderate
- severity level
- 7K units
- affected scope
- Class II
- classification
- June 10, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2203-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2203-2020) was formally reported on June 10, 2020, with the manufacturer initiating the action on April 30, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Cook Inc. is listed as the recalling firm, operating out of Bloomington, IN. Federal records list the affected scope as 6792.
The documented reason for this recall is: The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion. Distribution data in the federal record shows the product reached: Worldwide distribution including distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Ind…. 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
6792
Related Recalls
6
3 from same agency
Product description
Pressure Monitoring Set, C-PMS, G02838
Reason for recall
The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2203-2020 |
| Date reported | June 10, 2020 |
| Date initiated | April 30, 2020 |
| Recalling firm | Cook Inc. |
| Firm location | Bloomington, IN |
| Affected scope | 6792 |
| Distribution | Worldwide distribution including distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentuc… |
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-2203-2020) 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? ▼
Pressure Monitoring Set, C-PMS, G02838. Recalled by Cook Inc.. Units affected: 6792.
Why was this product recalled? ▼
The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 10, 2020. Severity: Moderate. Recall number: Z-2203-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution including distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2203-2020) 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 June 10, 2020. 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.