FDAAugust 11, 2016device
25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
What to do
FDA enforcement status: Terminated
Brands named
synergetics
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)2024-06-12
- FDABAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)2024-06-12
- FDABAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)2024-06-12
- FDABAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)2024-06-12
- FDA25 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.2016-08-11
- FDA25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.2016-08-11
- FDA25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.2016-08-11
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