Reported Oct 5, 2022 · Ongoing

Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260…

Cook Incorporated

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120

Is this the product you have?

18 of 18 products

Products covered by this recall
Model / number	Product as published
`G02261`	Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30
`G01937`	C-SF-25-40
`G00590`	TSF-18-260
`G01938`	C-SF-25-50
`G00652`	TSF-35-180
`G02255`	C-SF-18-40
`G00617`	TSF-25-145
`G00638`	TSF-32-145
`G02274`	C-SF-15-50
`G00587`	TSF-18-145
`G00593`	TSF-18-50
`G00650`	TSF-35-145
`G00602`	TSF-21-145
`G01237`	THSF-35-180
`G00664`	TSF-35-80
`G02163`	C-SF-25-30
`G02351`	C-SF-21-30
`G02408`	THSF-35-80

Lot codes and dates: C-SF-18-30 G02261 UDI-DI00827002022614
Lot/Expiration Date14795056 15-06-2027
C-SF-25-40 G01937 UDI-DI00827002019379
Lot/Expiration Date14795057 15-06-2027
TSF-18-260 G00590 UDI-DI00827002005907
Lot/Expiration date14795061 15-06-2027
C-SF-25-50 G01938 UDI-DI00827002019386
Lot/Expiration Date14795064 15-06-2027
TSF-35-180 G00652 UDI-DI00827002006522
Lot/Expiration Date
14795595
15-06-2027
14795596
15-06-2027
14798673
16-06-2027
14821167
30-06-2027
14822385
30-06-2027
14835601
11-07-2027
C-SF-18-40 G02255 UDI-DI00827002022553
Lot/Expiration Date14797774 16-06-2027
TSF-25-145 G00617 UDI-DI00827002006171
Lot/Expiration Date14798256 16-06-2027 14802353 20-06-2027 14821721 30-06-2027
TSF-32-145 G00638 UDI-DI00827002006386
Lot/Expiration Date14798677 16-06-2027
C-SF-15-50 G02274 UDI-DI00827002022744
Lot/Expiration Date14802345 20-06-2027
TSF-18-145 G00587 UDI-DI00827002005877
Lot/Expiration Date14802352 20-06-2027
TSF-18-50 G00593 UDI-DI00827002005938
Lot/Expiration Date14807597 22-06-2027
TSF-35-145 G00650 UDI-DI00827002006508
Lot/Expiration Date
84 of 84 codes
14809677
23-06-2027
14809679
23-06-2027
14809680
23-06-2027
14821849
30-06-2027
14821850
30-06-2027
14821851
30-06-2027
14821852
30-06-2027
14821853
30-06-2027
14821854
30-06-2027
14821855
30-06-2027
14827347
05-07-2027
14827348
05-07-2027
14827349
05-07-2027
14827350
05-07-2027
14827351
05-07-2027
14827352
05-07-2027
14827353
05-07-2027
14827354
05-07-2027
14827355
05-07-2027
14827356
05-07-2027
14827357
05-07-2027
14833106
08-07-2027
14833107
08-07-2027
14833108
08-07-2027
14833109
08-07-2027
14833110
08-07-2027
14833117
08-07-2027
14836092
11-07-2027
14836093
11-07-2027
14836094
11-07-2027
TSF-21-145 G00602 UDI-DI00827002006027
Lot/Expiration Date14813708 27-06-2027
THSF-35-180 G01237 UDI-DI00827002012370
Lot/Expiration Date14816669 28-06-2027
TSF-35-80 G00664 UDI-DI00827002006645 Lot/Expiration Date 14837671 12-07-2027
C-SF-25-30 G02163 UDI-DI00827002021631
Lot/Expiration DateNS14773823 07-06-2027
C-SF-21-30 G02351 UDI-DI00827002023512
Lot/Expiration DateNS14807611 22-06-2027
THSF-35-80 G02408 UDI-DI00827002024083
Lot/Expiration DateNS14837667 12-07-2027 NS14837685 12-07-2027
Amount recalled: 5,669 US; 5,286 OUS

This recall covers 24 products

The agency filed one notice per product. You are reading one of them; the other 23 are below.

11 more are in the archive.

Where it was sold

Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Other recalls from Cook Incorporated

15 in total.

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