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.
Reported: October 26, 2016 Initiated: August 11, 2016 #Z-0119-2017
Product Description
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.
Reason for Recall
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Details
- Recalling Firm
- Synergetics Inc
- Units Affected
- 72 units
- Distribution
- Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT. Foreign distribution to the UK, France, Mexico, and India.
- Location
- O Fallon, MO
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Synergetics Inc. Units affected: 72 units.
Why was this product recalled? ▼
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 26, 2016. Severity: Moderate. Recall number: Z-0119-2017.
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