Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each set contains: 1 peel-away sheath with built-in luer-lock; 1 vessel dilator; 1 50-cm guidewire 1 18-G needle; 1 10-cc syringe. Sterile EO. Manufacturer Oscor Inc. 3816 DeSoto Boulevard, Palm Harbor, FL 34683. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Models 6089, 6091, 6092, 6093, 6094, 6663 and 6664.
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-1443-05
- Quantity
- 19, 815
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
A manufacturer of 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
model 6089 lot numbers: C4-03103 thru C4-03707. model 6091 lot numbers: C4-03601 thru C4-03691. model 6092 lot numbers: C4-03110 thru C4-03684. model 6093 lot numbers: C4-03136 thru C4-03607. model 6094 lot numbers: C4-03501 thru C4-03610. model 6663 lot numbers: C4-03055 thru C4-03741. model 6663 lot numbers: C4-03280 thru C4-03445.
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.