Parks Medical Electronics Recalls Vascular Blood Flow Machines Due to Connection Error
Parks Medical Electronics is recalling 349 vascular blood flow machines after two incidents where an air supply tube was connected to a patient's IV instead of a blood pressure cuff.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Parks Medical Electronics, Inc. is recalling 349 units of vascular blood flow machines, including models 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. These devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities and are distributed with pressure cuffs of varying sizes as accessories.
The recall was initiated after the manufacturer became aware of two incidents where an air supply tube from the PARKS PVR unit was inadvertently connected to an IV in the patient's arm instead of into the blood pressure cuff. The agency has classified this recall as Class II.
The affected devices were distributed worldwide, including nationwide in the USA and in countries such as Australia, Brazil, Canada, Chile, Egypt, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Mexico, Peru, Republica Argentina, Spain, Switzerland, and Venezuela. A total of 270 units were distributed domestically and 79 units were distributed foreignly. Healthcare facilities and consumers should identify affected units by model number and distribution codes and contact the manufacturer for instructions.
The recalled product
- 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…
- Manufacturer
- Parks Medical Electronics, Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Domestic Distribution: 013053
- 013104
- 013107
- 013124
- 013154
- 013182
- 013193
- 014203
- 014237
- 014248
- 014249
- 014252
- 014253
- 014254
- 014269
- 014276
- 014310
- 014335
- 014339
- 014361
Distribution
Distributed nationwide across the United States.
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