Agency classClass IIOur severity:High FDA (Devices)·Z-0891-2014·Announced 2014-02-05

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.

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 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
Hazard: seal-failure
sterility-compromise
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.

See all 28 products in this recall →

Same manufacturer · Synergetics Inc

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