Recall Z-0580-2010
Greatbatch Medical · initiated September 1, 2009
Product
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.
Codes / lots: 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.
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.
FDA-determined 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.
Details
- Recall number
- Z-0580-2010
- Initiated
- September 1, 2009
- Posted by FDA
- December 29, 2009
- Terminated
- December 17, 2011
- Product code
- DTB – Permanent Pacemaker Electrode
- Quantity
- 45 units
- Distribution
- CA and MN
- Recalling firm
- Greatbatch Medical, Minneapolis, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0581-2010 | Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner…The silicone tubing of affected leads was processed outside of validated parameters. Although the material… | 09/01/2009Terminated |