Z-0877-2014 Class II Terminated
FDA device recall Z-0877-2014 was initiated by Synergetics Inc on Dec 9, 2013 and is designated Class II. Reason for recall: Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. The recall status is terminated (terminated Mar 25, 2015). Affected quantity: 36 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 5, 2014
- Initiation Date
- Dec 9, 2013
- Termination Date
- Mar 25, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 units
Product Description
25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. 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.
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.
Code Information
Lot number: M269200
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0877-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026