RecallRadar

FDA Device recall Z-0957-2018

Fixed Core Bentson

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

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0957-2018
ClassificationClass II
Statusterminated
Initiated2017-10-13
Published2018-03-21
Last updated2026-09-13 11:54 UTC
CompanyCook
Distributionn/a

Product

Fixed Core Bentson

Reason

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

Identifiers

code_infoCatalog # TSCFB-/-BH Affected lots range from: F3734676 - F4911986 NS4938980 - NS6144078

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-0957-2018%22

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