Guidant Lead Tunneler Kit model 6927. Accessory Kit for use with the Endotak SQ Lead Array. Contains one tunneler and four sheaths. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue, St. Paul, MN 55112-5798.
This recall has been terminated (originally issued August 30, 2005).
- Company
- Guidant Corporation
- Recall Initiated
- June 13, 2005
- Posted
- August 30, 2005
- Terminated
- January 5, 2007
- Recall Number
- Z-1442-05
- Quantity
- 278
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
A manufacturer for Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use.
Distribution
nationwide and worldwide.
Lot / Code Info
lot number 104029 thru 105078
Root Cause
Other
Action Taken
By Telephone, 6/13/2005. Guidant Sales Reps are to visit hospitals to remove any remaining inventory. Dear Hospital Administrator letter may be left with hospital to explain the removal of product.
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