FDA Device

Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)'' Catalog # 06607 (Oscor) and 666089-201 (Guidant)

Hazard

Sheath size is larger than dilator size causing insertion difficulties.

What You Should Do

Remedy

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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Products

Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)'' Catalog # 06607 (Oscor) and 666089-201 (Guidant)
Brand
Oscor Inc.
UPC
BBraun Lot # 60710907 and 60710908 Oscor Lot # OL09342-1 and OL9645-01

Units Affected

6985

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