FDA Medical Device Recalls (openFDA)
Spectranetics Corporation: Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907.
- Recall number
- Z-0698-2008
- Recalling firm
- Spectranetics Corporation
- Product
- Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907.
- Status
- Terminated
- Initiated
- 2007-12-10
- Posted
- 2008-02-05
- Terminated
- 2008-02-08
- Reason
- Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number 518-037, 135 cm--the exterior box labeling is correct as 90 cm.
- Root cause
- Packaging process control
- Action
- Consignees were notified by Dear Healthcare provider letter on 12/10/2007 and were told that a sales rep would remove and replace all affected catheters.
- Quantity
- 64
- Distribution
- Nationwide including states of FL, IL, IN, MO, NC, NY, TX, and UT.
- Lot, serial or model codes
- Lot Number: 0709158
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 3007284006
- Firm city
- Colorado Springs
- Firm state
- CO
- 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