Recall Z-1843-2022— Cook Incorporated

Name: FDA recall Z-1843-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-16

Class II · Ongoing

Class II FDA medical device recall by Cook Incorporated, initiated 2022-08-16. It names one FDA 510(k) clearance: K171997. Product: Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304. Reason: Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised..

Recalling firm: Cook Incorporated
Classification: Class II
Status: Ongoing
Initiated: 2022-08-16
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K171997 — Mandril Wire GuideCook Incorporated·cleared 2018-03-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304

Reason for recall

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

Data sourced from openFDA. This site is unofficial and independent of the FDA.