Synergetics Inc: Medical Device Recall in 2014 - (Recall #: Z-0891-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 9, 2013

Date Posted: February 5, 2014

Recall Number: Z-0891-2014

Event ID: 67147

Reason for Recall:

Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.

Status: Terminated

Product Quantity: 36 units

Code Information:

Lot numbers: M264400, M265330, and M270010

Distribution Pattern:

Worldwide Distribution-USA (nationwide) and the countries of 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.

Voluntary or Mandated:

Voluntary: Firm initiated