Hearth Record

BD PYXIS MEDBANK MINI CR-4HH-P

Medical device recall Z-2486-2024. Published in FDA’s Enforcement Report on Aug 14, 2024.

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 Aug 14, 2024. 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?

Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

Source:

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

Which ones are recalled?

BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9

232 units, in FDA’s words.

Source:

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

Codes to check against yours

UDI: 10885403512544/ Serial Number: 16170661 16210908 16089019 16062433 16147169 16080412 16124906 15940375 15940373 15940374 15940376 15957620 15957621 15941307 15967410 15967412 15967409 15967413 15967411 15967361 15943774 16056924…

Every code shown here, 1,998 characters

UDI: 10885403512544/ Serial Number: 16170661 16210908 16089019 16062433 16147169 16080412 16124906 15940375 15940373 15940374 15940376 15957620 15957621 15941307 15967410 15967412 15967409 15967413 15967411 15967361 15943774 16056924 16188928 15943781 15943470 15943782 15872417 15902417 15902418 15888968 15253736 15253737 16247094 16283979 16225069 16222611 16165533 16205727 16270832 16200474 16244810 16250223 15935617 15654707 15654706 15489245 15723803 15927979 15924532 15569608 15832680 15832679 15824206 15815815 15815825 15415136 15415135 15415137 15415138 15622987 16174396 16193269 15939084 15939085 15854218 15854728 15854727 15398915 15383489 15489244 15489243 15606150 15606167 15924529 15888948 15924530 15924528 15569630 15575989 15575996 15575979 15575978 15575988 15575986 15575985 15569629 15575975 15587203 15587204 15587205 15824205 15824210 15824221 15815826 15815830 15852349 15852348 15353925 15353926 15422146 15422154 15422152 15422155 15422153 15422149 15422148 15422151 15422147 15422156 15422158 15422157 15939254 15939255 15783795 15783783 15853040 15398907 15398905 15398913 15666771 15226385 15227522 15204115 15204117 15550828 15550861 15929562 15929561 15929563 15930792 15930790 15930783 15930785 15930791 15930788 15930784 15930789 15930787 15930793 15929564 15930786 15645828 15645826 15645830 15248755 15248757 15248758 15282139 15282134 15295949 15353927 15353929 15353930 15282137 15257953 15282141 15260920 15920015 15920012 15920013 15921449 15921445 15921447 15921741 15921742 15921740 15921743 15363281 15923974 15923971 15923973 15923975 15923970 15923972 15504830 15504825 15504832 15504827 15504820 15504822 15504819 15504829 15504823 15639723 15639722 15639729 15933707 15933710 15933713 15933709 15933708 15933715 15933714 15933711 15933739 15935598 15935594 15935592 15935628 15935590 15935587 15935588 15935589 15935599 15935593 15935591 15935600 15935595 15935601 15935602 15935625 15935624 15743383 15600756 15600757 15441364 15441362 15441367…

FDA’s list runs to 2,123 characters. The first part is shown; the rest is on FDA’s record.

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.

US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV.

The states and territories these words name

41 states and territories.

Every one of them
  • Alabama
  • Arizona
  • California
  • Colorado
  • Connecticut
  • Florida
  • Georgia
  • Iowa
  • Idaho
  • Illinois
  • Indiana
  • Kansas
  • Kentucky
  • Louisiana
  • Massachusetts
  • Maryland
  • Maine
  • Michigan
  • Minnesota
  • Missouri
  • Mississippi
  • Montana
  • North Carolina
  • North Dakota
  • New Hampshire
  • New Jersey
  • Nevada
  • New York
  • Ohio
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Virginia
  • Washington
  • Wisconsin
  • West Virginia

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.

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 Jun 24, 2024.
  • FDA classified it on Aug 2, 2024.
  • FDA’s Enforcement Report published it on Aug 14, 2024.
Source:

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

Who is recalling it?

  • CareFusion 303, Inc., of San Diego, CA.
  • 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.”
  • FDA’s list of codes runs to 2,123 characters; the first part is shown here, and the rest is on FDA’s record.
  • 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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Every fact names its source.

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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