FDA Medical Device Recalls (openFDA)
Oscor Inc.: Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)'' Catalog # 06607 (Oscor) and 666089-201 (Guidant)
- Recall number
- Z-0345-06
- 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)
- Status
- Terminated
- Initiated
- 2005-09-13
- Posted
- 2006-01-06
- Terminated
- 2012-07-08
- Reason
- Sheath size is larger than dilator size causing insertion difficulties.
- 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
- 6985
- Distribution
- Distributed throughout the United States and to several foreign countries including China, Japan, Germany and the Phillippines.
- Lot, serial or model codes
- BBraun Lot # 60710907 and 60710908 Oscor Lot # OL09342-1 and OL9645-01
- 510(k) numbers
- ["K871153"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1035166
- Firm city
- Palm Harbor
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28