RecallRadar

FDA Device recall Z-0953-2018

Bentson Wire Guide

On 2018-03-21 the FDA classified a Class II recall of Bentson Wire Guide by Cook, citing label does not state that the product is heparin-coated.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0953-2018
ClassificationClass II
Statusterminated
Initiated2017-10-13
Published2018-03-21
Last updated2026-09-13 11:54 UTC
CompanyCook
Distributionn/a

Product

Bentson Wire Guide

Reason

Label does not state that the product is heparin-coated.

Identifiers

code_infoCatalog # TSFB-/-BH Affected lots include: F3813488 - F4859795 NS5327890 - NS6060291 3730884 - 5984142 F3746894 - F4920488 NS4937520 - NS6252870

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0953-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.