RecallRadar

FDA Device recall Z-0956-2018

Double Flexible Tipped Wire Guide

On 2018-03-21 the FDA classified a Class II recall of Double Flexible Tipped 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-0956-2018
ClassificationClass II
Statusterminated
Initiated2017-10-13
Published2018-03-21
Last updated2026-09-13 11:54 UTC
CompanyCook
Distributionn/a

Product

Double Flexible Tipped Wire Guide

Reason

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

Identifiers

code_info
Catalog # DTDW-/-BW Affected lots include: F3749839 - F4849938 NS5085893 - NS5827127 F4628078 - F4856722 376318…Catalog # DTDW-/-BW Affected lots include: F3749839 - F4849938 NS5085893 - NS5827127 F4628078 - F4856722 3763189 - 6106860 F3739663 - F4916737 NS4980257 - NS6098990

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-0956-2018%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.