FDA Medical Device Recalls (openFDA)
Cook Inc.: Fixed Core Wire Guide
- Recall number
- Z-0958-2018
- Recalling firm
- Cook Inc.
- Product
- Fixed Core Wire Guide
- Status
- Terminated
- Initiated
- 2017-10-13
- Posted
- not on file
- Terminated
- 2019-10-23
- Reason
- Label does not state that the product is heparin-coated.
- Root cause
- Labeling Change Control
- Action
- On October 31, 2017 an URGENT MEDICAL DEVICE CORRECTION was issued to customers requesting the following, including a corrective action: Step 1: Determine if your product is included in the affected lot ranges by comparing your lot number to the listing provided. " If your product is not affected, complete the Acknowledgement and Receipt Form. " If your product is affected, proceed to Step 2. Step 2: Remove a Heparin Coated label from the label sheet provided and apply to the top right corner of your affected unit. o If you need additional labels, please contact Stericycle at 855.215.4967. If you would like assistance, representatives are available to support you. To request assistance, please contact Stericycle at 855.215.4967
- Quantity
- 601,778
- Distribution
- Nationally
- Lot, serial or model codes
- Catalog # C-SCF-/-BH C-SF-/-BH SF-/-BH THSCF-/-BH THSF-/-BH TSCF-/-BH TSCFR-/-BH TSF-/-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182 Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894 F3753452 - F4925547 NS5008794 - NS6171324 F3922830 - F4218188 NS5470403 - NS6020850 F4087814 - F4741344 NS4929840 - NS5104065 F4119548 - F4920483 NS5171771 - NS6144080 3730875 - 6180567 F3730082 - F4924418 NS4928022 - NS6177724 NS5185993 3730101 - 6181269 F3734860 - F4923958 NS4927349 - NS6203187
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DQX
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- 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