Synergetics VersaVit 2.0 Procedure Packs Recalled for Pressure Defect
Synergetics Inc is recalling 72 units of 25 gauge VersaVit 2.0 Core Essentials Procedure Packs because the vitrectomy cutters do not operate within correct pressure pulse specifications.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, an FDA Class II recall is assigned a severity score of 4 (Severe), particularly when it involves a functional defect in a medical device that could lead to adverse health consequences.
Plain-English summary
Synergetics Inc is recalling 72 units of the 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E. The devices are packaged in HIPS rigid trays with a Tyvek lid sterile barrier system. The recall involves two specific lots: M545040 (expiration 10/2018) and M586070 (expiration 03/2019), each available as single units or boxes of six.
The recall was initiated because the vitrectomy cutters in these packs were found not to be operating within the correct pressure pulse per specification. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected devices were distributed to healthcare facilities in Kentucky, Virginia, Tennessee, Ohio, Indiana, California, New Jersey, New York, Texas, South Carolina, Alabama, Mississippi, Michigan, and Utah. Additionally, the devices were distributed to the United Kingdom, France, Mexico, and India. Healthcare providers should stop using the affected lots and contact Synergetics Inc for further instructions.
The recalled product
- Product
- 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
- Manufacturer
- Synergetics Inc
- Hazard
- Affected units
- 72
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 (3)
- Lot number M545040 (1 each or box of 6 each)
- exp 10/2018 Lot number M586070 (1 each or box of 6 each)
- exp 03/2019
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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