Z-0345-06

Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set * Model: LLP-7 * Size: 7F (2.33mm)''...

Name: Z-0345-06 Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)''...
Creator: Oscor Inc.
Published: 2005-09-13
License: https://open.fda.gov/license/

Oscor Inc. / initiated 2005-09-13 / Terminated

FDA source

Oscor Inc. began a recall of Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)'' Catalog # 06607 (Oscor) and 666089-201 (Guidant) on 2005-09-13. The reason FDA records is "Sheath size is larger than dilator size causing insertion difficulties". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0345-06
Status: Terminated
Initiated: 2005-09-13
Posted: 2006-01-06
Terminated: 2012-07-08
Recalling firm: Oscor Inc.
Product: Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)'' Catalog # 06607 (Oscor) and 666089-201 (Guidant)
Product code: DYB Introducer, Catheter
Reason for recall: Sheath size is larger than dilator size causing insertion difficulties.
FDA root cause: Other
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.
Quantity in commerce: 6985
Distribution: Distributed throughout the United States and to several foreign countries including China, Japan, Germany and the Phillippines.
Product codes and lots: BBraun Lot # 60710907 and 60710908 Oscor Lot # OL09342-1 and OL9645-01

Product code DYB

K871153Class IICatheter IntroducerAngeion Corp. / cleared 1987-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)