Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized by ethylene-oxide gas. Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.
This recall has been terminated (originally issued December 29, 2009).
- Company
- Greatbatch Medical
- Recall Initiated
- September 1, 2009
- Posted
- December 29, 2009
- Terminated
- December 17, 2011
- Recall Number
- Z-0580-2010
- Quantity
- 45 units
- Firm Location
- North Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available.
Distribution
CA and MN
Lot / Code Info
Serial numbers: 148236, 148237, 148238, 148239, 148240, 148241, 148242, 148243, 148036, 148038, 148039, 148040, 148041, 148042, 148043, 148044, 148045, 148046, 148047, 148048, 148049, 148050, 148051, 148052, 148053, 148054, 148055, 148056, 148057, 148058, 148059, 148060, 148061, 148063, 148064, 148065, 148066, 148067, 148068, 148069, 148070, 148071, 148072, 148074, 148075.
Root Cause
Component change control
Action Taken
Customers were contacted by phone beginning 09/01/09. They were asked to hold product and determine if they had distributed any product. A written notification followed which identified the product, described the issue and asked for product to be returned. Product was distributed to two consignees and contained the following day. Questions are directed to the company at 612-559-2613.