Hearth Record

Vinyl Connecting Tube, Connecting Tube Reference

Medical device recall Z-1844-2022. Published in FDA’s Enforcement Report on Oct 5, 2022.

FDA’s own record, on accessdata.fda.gov

No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.

The short answer

Published in FDA’s Enforcement Report on Oct 5, 2022. Copied from openFDA on Oct 20, 2026.

Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.

How serious is it, by FDA’s class?

Class II, the middle of FDA’s three classes.

“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”

openFDA, in plain words, its enforcement report fields.

“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

FDA’s rule, 21 CFR 7.3(m)(2), eCFR.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

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.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898

240 US; 108 OUS, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

CTU14.0-30-ST G02278 UDI-DI: 00827002022782 Lots/Expiration Date: 14806993 22-06-2025 14806994 22-06-2025 14806997 22-06-2025 14807003 22-06-2025 14809136 23-06-2025 14809138 23-06-2025 14809140 23-06-2025 14809141 23-06-2025 14811461…

Every code shown here, 1,813 characters

CTU14.0-30-ST G02278 UDI-DI: 00827002022782 Lots/Expiration Date: 14806993 22-06-2025 14806994 22-06-2025 14806997 22-06-2025 14807003 22-06-2025 14809136 23-06-2025 14809138 23-06-2025 14809140 23-06-2025 14809141 23-06-2025 14811461 24-06-2025 14823426 01-07-2025 14823427 01-07-2025 14823428 01-07-2025 14823429 01-07-2025 14826334 05-07-2025 14826335 05-07-2025 14826337 05-07-2025 14826338 05-07-2025 14831013 07-07-2025 14831014 07-07-2025 14832846 08-07-2025 14833913 08-07-2025 14834825 11-07-2025 14835074 11-07-2025 14835079 11-07-2025 14835400 11-07-2025 14835401 11-07-2025 14836968 12-07-2025 14836973 12-07-2025 14836974 12-07-2025 14836975 12-07-2025 14841346 14-07-2025 14844979 18-07-2025 14844980 18-07-2025 14844981 18-07-2025 14844983 18-07-2025 14844984 18-07-2025 14847734 19-07-2025 14847738 19-07-2025 NS14809137 23-06-2025 NS14832847 08-07-2025 CTU14.0-40-ST G02327 UDI-DI: 00827002023277 Lots/Expiration Date: 14811457 24-06-2025 14811459 24-06-2025 14811460 24-06-2025 14821325 30-06-2025 14821326 30-06-2025 14826333 05-07-2025 14831010 07-07-2025 14832848 08-07-2025 14835078 11-07-2025 14847740 19-07-2025 NS14818298 29-06-2025 CTU14.0-30 G02791 UDI-DI: 00827002027916 Lots/Expiration Dates: 14816266 28-06-2025 14816268 28-06-2025 14816269 28-06-2025 14816273 28-06-2025 14834821 11-07-2025 14835076 11-07-2025 14835077 11-07-2025 14841348 14-07-2025 14841352 14-07-2025 14847735 19-07-2025 NS14816264 28-06-2025 NS14816265 28-06-2025 NS14831012 07-07-2025 NS14851689 21-07-2025 CTU14.0-50-ST G02464 UDI-DI: 00827002024649 Lots/Expiration Date: 14816271 28-06-2025 14831009 07-07-2025 NS14813459 27-06-2025 NS14826331 05-07-2025 NS14826336 05-07-2025 NS14841345 14-07-2025 C-CTU14.0-30-ST G02898 UDI-DI: 00827002028982 Lots/Expiration Date: 14826332 05-07-2025 NS14816270 28-06-2025

Source:

Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.

Where did it go?

FDA’s words for the “general area of initial distribution”: where the firm first shipped it.

Domestic distribution nationwide. Foreign distribution worldwide.

These words name no state.

What FDA means by nationwide

“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”

openFDA, its enforcement report fields.

The words say it went outside the United States too.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

Is it still going on?

Ongoing, in FDA’s file.

“A recall which is currently in progress.”

openFDA, on “On-Going”, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Aug 16, 2022.
  • FDA classified it on Sep 28, 2022.
  • FDA’s Enforcement Report published it on Oct 5, 2022.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Cook Incorporated, of Bloomington, IN.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

What this record can’t tell you

  • Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
  • Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
  • How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
  • Whether anyone was hurt or fell ill: the report doesn’t say.
  • How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
  • A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Source:

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

  • U.S. Food and Drug Administration, Device recall enforcement reports.

    Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.

Source:

Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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