Z-1443-05

Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each set contains: 1 peel-away...

Name: Z-1443-05 Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each set contains: 1 peel-away...
Creator: Guidant Corporation
Published: 2005-06-13
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-06-13 / Terminated / root cause: manufacturing process

FDA source

Guidant Corporation began a recall of 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... on 2005-06-13. The reason FDA records is "A manufacturer of Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1443-05
Status: Terminated
Initiated: 2005-06-13
Posted: 2005-08-30
Terminated: 2007-01-05
Recalling firm: Boston Scientific Corporation
Product: 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.
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Other
Action: 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.
Quantity in commerce: 19, 815
Distribution: nationwide and worldwide.
Product codes and lots: 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.

Product code DYB

K831751Class IILead Introducer Sets-Eb-S8 & Eb-S12Oscor, Inc. / cleared 1983-10-20

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)