Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)'' Catalog # 06607 (Oscor) and 666089-201 (Guidant)
- Company
- Oscor, Inc.
- Recall Initiated
- September 13, 2005
- Posted
- January 6, 2006
- Terminated
- July 8, 2012
- Recall Number
- Z-0345-06
- Quantity
- 6985
- Firm Location
- Palm Harbor, FL
Reason for Recall
Sheath size is larger than dilator size causing insertion difficulties.
Distribution
Distributed throughout the United States and to several foreign countries including China, Japan, Germany and the Phillippines.
Lot / Code Info
BBraun Lot # 60710907 and 60710908 Oscor Lot # OL09342-1 and OL9645-01
Root Cause
Other
Action Taken
The firm will issue a recall letter to its consignees informing them of the recall. The letter will ask the consignees to return the devices from affected lot numbers for replacement. The returned products will be individually inspected.
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