Z-1828-2022Class II

Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356...

Name: Z-1828-2022 Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356...
Creator: Cook Incorporated
Published: 2022-08-16
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2022-08-16 / Open, Classified / root cause: packaging

FDA source

Cook Incorporated began a recall of Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621... on 2022-08-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1828-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-16
Posted: 2022-09-28
Recalling firm: Cook Incorporated
Product: Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268
Product code: DQX Wire, Guide, Catheter
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.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On August 16, 2022, Cook Medical notified affected customers of the recall. Customers were instructed to immediately cease all further distribution and use of the affected products. Affected product should be quarantined and returned to Cook Medical to receive product credit. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235
Quantity in commerce: 1,236 US
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
Product codes and lots: THSF-35-145-COONS G02356 UDI-DI 00827002023567 Lot/Expiration Date 14757818 27-05-2027 14795059 15-06-2027 14797781 16-06-2027 14802363 20-06-2027 THSF-38-145-COONS G02324 UDI-DI 00827002023246 Lot/Expiration Date 14793057 14-06-2027 THSF-35-180-COONS G02621 UDI-DI 00827002026216 Lot/Expiration Date 14797773 16-06-2027 THSF-35-80-COONS G12268

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1828-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1824-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1825-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1826-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1827-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1828-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1829-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1830-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1831-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1832-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1833-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1834-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1835-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1836-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1837-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1838-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1839-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1840-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1841-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1842-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1843-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1844-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1845-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1846-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1847-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28

Product code DQX

K171764Class IIFixed Core Wire GuidesCook Incorporated / cleared 2018-03-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)