Impact Instrumentation Recalls Ten Model 731 EMV+ Uni-Vent Devices
Impact Instrumentation is recalling ten Model 731 EMV+ Uni-Vent devices shipped before verification of a new integrated circuit was completed.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and no specific injuries or illnesses are reported in the source text.
Plain-English summary
Impact Instrumentation, Inc. is recalling ten units of the Model 731 EMV+ Uni-Vent. These devices are indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation.
The recall was initiated because the devices were shipped out in error before the verification and validation process was completed for a new integrated circuit (IC) on the CPU PCB. The affected units were distributed to the state of Illinois.
The ten affected units have the following serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, and VCDB120297. Healthcare facilities and consumers should check their inventory for these specific serial numbers and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.
- Manufacturer
- Impact Instrumentation, Inc.
- Hazard
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 (10)
- Serial numbers: VCDB120315
- VCDB120316
- VCDB120299
- VCDB120300
- VCDB120313
- VCDB120307
- VCDB120312
- VCDB120303
- VCDB120310
- VCDB120297.
Distribution
Distributed in 1 state:
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