Recall Z-0897-2014— Synergetics Inc
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: 25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. 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
25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. 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.