Recalls / —
—#161591
Product
Fixed Core Bentson
- FDA product code
- DQX — Wire, Guide, Catheter
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- Affected lot / code info
- Catalog # TSCFB-/-BH Affected lots range from: F3734676 - F4911986 NS4938980 - NS6144078
Why it was recalled
Label does not state that the product is heparin-coated.
Root cause (FDA determination)
Labeling Change Control
Action the firm took
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
Recalling firm
- Firm
- Cook Inc.
- Address
- 750 N Daniels Way, Bloomington, Indiana 47404-9120
Distribution
- Distribution pattern
- Nationally
Timeline
- Recall initiated
- 2017-10-13
- Terminated
- 2019-10-23
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #161591. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.