Synergetics Recalls Two-Port Vitrectomy End Irrigators Due to Seal Failure
Synergetics is recalling specific lots of Two-Port Vitrectomy End Irrigators because faulty seals on the outer pouch could fail, compromising sterility.
What this means for you
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 risk-of-harm product (sterile medical device) where a seal failure could compromise sterility, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Synergetics, Inc. is recalling 36 units of Two-Port Vitrectomy (TPV) Wide Field High Flow End Irrigators. The affected devices are 19-gauge, 7.0 feet in length, and packed 12 units per box. The recall covers lot numbers M264400, M265330, and M270010.
The recall was initiated because faulty seals on the outer pouch of these double-pouched, single-use, sterile ophthalmic devices could result in seal failure. This defect poses a risk to the sterility of the medical device.
The affected units were distributed nationwide in the United States and internationally to Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom. Healthcare providers and facilities should stop using the affected lots and contact Synergetics for instructions on return or replacement.
The recalled product
- Product
- Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc., 19ga, length 7.0 ft, sterile / EO, 56.14. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Category
- Medical Device — Ophthalmic
- Affected units
- 36
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 numbers: M264400
- M265330
- and M270010
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 28 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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