Devices includes a Multi Port Inflator or without Multi Port Inflator — Class II medical device recall Z-0443-2013
Terminated recall by Parks Medical Electronics, Inc, reported 2012-12-05, distributed nationwide. Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR
| Recall number | Z-0443-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Parks Medical Electronics, Inc, Aloha, OR, United States |
| Recall initiated | 2012-08-08 |
| Classified | 2012-11-27 |
| Reported by FDA | 2012-12-05 |
| Terminated | 2016-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CH, CL, DE, EG, ES, GR, HK, IL, IN, IT, JP, KR, MX, PE, VE |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0443-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.