Weck, DermaHook", Catalog #382805, 1/2" (12mm) Neuro Elastic Retractors, Sterile, Rx only, Weck Closure Systems, 2917 Weck Drive, Research Triangle Park, NC 27709
This recall has been terminated (originally issued September 4, 2008).
- Company
- Telefelx Medical
- Recall Initiated
- May 12, 2008
- Posted
- September 4, 2008
- Terminated
- April 19, 2012
- Recall Number
- Z-1857-2008
- Quantity
- 8492 units
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The bands are breaking within the sealed packaging or in use prior to the expiration dates.
Distribution
U.S., Argentina, Australia, Brazil, Canada, Costa Rica, France, Mexico, Puerto Rico, Singapore, and the Virgin Islands
Lot / Code Info
Catalog #382805, All manufacturing dates from 4/1/2006 through 3/19/2008; Lot numbers: 01A0800086, 01A0800168, 01A0822216, 01A0800323, 01L0700096, 01L0700257, 1996021, 2230335, 2614566, T1206008, T1206537, T1209084, T1209085, T1209525, T1211001, T1211685, T1212658, T1223079, T1226004, T1227679, T1229934, T1231416, T1233264, T1234305, T1236177, T1239174, T1242796,T1243832, T1243833, T1243834, T1247442, T1250478, T1251531, T1252452, T1254316, T1255368, T1256381, T1257718, T1258301, T1266798, T1267798, T1268854, T1269783, T1270679, T1271622, T1277206, T1277284, T1279907.
Root Cause
Incorrect or no expiration date
Action Taken
Consignees were notified by letter via UPS next day, on/about 05/12/2008. They were instructed to return all affected product or acknowledge that the product no longer exists. They were further instructed to forward the letter to if they have further distributed the affected lots into institutional settings or to homecare patients and retrieve relevant product from those locations. If you require additional information or clarification regarding this matter, please contact Jackie Warner at 1-800-334-9751, ext. 4973.