Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)'' Catalog # 06607 (Oscor) and 666089-201 (Guidant)
FDA Recall Z-0345-06 · Posted 2006-01-06
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Recalling FirmOscor Inc.
Recall StatusTerminated
Product CodeDYB
Date Initiated2005-09-13
Date Terminated2012-07-08
Product Quantity6985
Reason for Recall
Sheath size is larger than dilator size causing insertion difficulties.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Distributed throughout the United States and to several foreign countries including China, Japan, Germany and the Phillippines.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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