Z-1827-2022Class II

Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80...

Name: Z-1827-2022 Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80...
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 Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200... 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-1827-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-16
Posted: 2022-09-28
Recalling firm: Cook Incorporated
Product: Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)
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: 5571 US, 409 OUS
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
Product codes and lots: TSFB-35-80 (GPN G01315) UDI-DI 00827002270411 Lots 14751376 Expiration Date 25-05-2027 TSFB-35-145 (GPN G00691) UDI-DI 00827002006911 Lots Expiration Dates 14813687 27-06-2027 14831302 07-07-2027 14831303 07-07-2027 14831304 07-07-2027 14831305 07-07-2027 14831307 07-07-2027 14831308 07-07-2027 14831309 07-07-2027 14831310 07-07-2027 14831311 07-07-2027 14831313 07-07-2027 14842394 14-07-2027 14842395 14-07-2027 14842396 14-07-2027 14842397 14-07-2027 14842398 14-07-2027 14842399 14-07-2027 14842400 14-07-2027 14842401 14-07-2027 TSFB-35-200 (GPN G01095) UDI-DI 00827002010956 Lot/Expiration Date: 14816668 28-06-2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1827-2022
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)