Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 5, 2012
Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages i
Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR unit was inadvertently connected to an IV in the patient's arm inst…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Parks Medical Electronics, Inc recalled Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the dev… - a moderate-severity action.
Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the dev… was recalled by Parks Medical Electronics, Inc in December 5, 2012. Reason: Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PV…. Check the official notice for the remedy. Verify recall #Z-0443-2013 with the FDA Devices before acting.
The recall
Parks Medical Electronics, Inc issued this moderate-severity FDA Devices recall-Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PV….
- Moderate
- severity level
- 349 units
- affected scope
- Class II
- classification
- December 5, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0443-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0443-2013) was formally reported on December 5, 2012, with the manufacturer initiating the action on August 8, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Parks Medical Electronics, Inc is listed as the recalling firm, operating out of Aloha, OR. Federal records list the affected scope as 349 units (Domestic: 270 units - Foreign: 79 units).
The documented reason for this recall is: Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR unit was inadvertently connected to an IV in the patient's arm instead of into the blood pressure cuff. Distribution data in the federal record shows the product reached: Worldwide distribution: USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, Egypt, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Mexico, Peru, Republica Argentina, Spain, Switzerland, …. 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
349 units (Domestic: 270 units - Foreign: 79 units)
Related Recalls
6
3 from same agency
Product description
Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.
Reason for recall
Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR unit was inadvertently connected to an IV in the patient's arm instead of into the blood pressure cuff.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0443-2013 |
| Date reported | December 5, 2012 |
| Date initiated | August 8, 2012 |
| Recalling firm | Parks Medical Electronics, Inc |
| Firm location | Aloha, OR |
| Affected scope | 349 units (Domestic: 270 units - Foreign: 79 units) |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, Egypt, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Mexico, Peru, Republica Argentina, Spain, Switzerland, and Venezuela. |
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-0443-2013) 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? ▼
Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.. Recalled by Parks Medical Electronics, Inc. Units affected: 349 units (Domestic: 270 units - Foreign: 79 units).
Why was this product recalled? ▼
Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR unit was inadvertently connected to an IV in the patient's arm instead of into the blood pressure cuff.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 5, 2012. Severity: Moderate. Recall number: Z-0443-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, Egypt, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Mexico, Peru, Republica Argentina, Spain, Switzerland, and Venezuela..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0443-2013) 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 December 5, 2012. 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.