Synergetics VersaVit 2.0 Procedure Packs Recalled for Pressure Defect
Synergetics Inc is recalling 255 units of 25 gauge VersaVit 2.0 Procedure Packs because the vitrectomy cutters are not operating within the correct pressure pulse specifications.
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 involves a medical device with a functional defect (pressure pulse specification) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Synergetics Inc is recalling 255 units of 25 gauge VersaVit 2.0 Procedure Packs with Photon Wide Field Illuminator, Product/Part Number 70025SP. The devices are packaged in HIPS rigid trays with a Tyvek lid sterile barrier system.
The recall is being conducted because the vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. The affected lots are M543990, M545780, M569020, and M578140, with expiration dates ranging from October 2018 to February 2019.
The devices were distributed to facilities in Kentucky, Virginia, Tennessee, Ohio, Indiana, California, New Jersey, New York, Texas, South Carolina, Alabama, Mississippi, Michigan, and Utah. Foreign distribution occurred in the United Kingdom, France, Mexico, and India. Healthcare providers should stop using the affected devices and contact Synergetics Inc for further instructions.
The recalled product
- Product
- 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
- Manufacturer
- Synergetics Inc
- Hazard
- Affected units
- 255
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 (5)
- Lot number M543990 (1 each or box of 6 each)
- exp 10/2018 Lot number M545780 (1 each or box of 6 each)
- exp 10/2018 Lot number M569020 (1 each or box of 6 each)
- exp 01/2019 Lot number M578140 (1 each or box of 6 each)
- exp 02/2019
Distribution
Part of a larger recall action
This product is one of 4 recalled by Synergetics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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