Recall Z-0883-2014— Synergetics Inc

Name: FDA recall Z-0883-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-09

Class II · Terminated

Class II FDA medical device recall by Synergetics Inc, initiated 2013-12-09, terminated 2015-03-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.. Reason: Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure..

Recalling firm: Synergetics Inc
Classification: Class II
Status: Terminated
Initiated: 2013-12-09
Terminated: 2015-03-25
Firm location: O Fallon, MO, United States

Product description

Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.