Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are
Medical device recall Z-3107-2017. Published in FDA’s Enforcement Report on Sep 13, 2017.
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 Sep 13, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 184,102 kits how much, in FDA’s words
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide” 22GA 1¿ inch Needles. BD subsequently recalled these needles because, “ Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures
184,102 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CATALOG # CS WO (LOT)_# 05A7593 407625 05A7593 412059 05A7593 420879 09-4733A 503927 09-4733A 611913 13-A3858B 588354 13-A3858B 619381 13-A3858B 647955 22-0758B 412013 22-0758B 414835 26-2503 485950 26-2503 604487 26-2503 643270 26-2503…
Every code shown here, 1,991 characters
CATALOG # CS WO (LOT)_# 05A7593 407625 05A7593 412059 05A7593 420879 09-4733A 503927 09-4733A 611913 13-A3858B 588354 13-A3858B 619381 13-A3858B 647955 22-0758B 412013 22-0758B 414835 26-2503 485950 26-2503 604487 26-2503 643270 26-2503 673080 26-2927 407083 26-2927 416194 26-9079A 594214 26-9079A 621261 26-9079A 647250 26-9079A 672502 26-9079A 715637 26A2503 642655 26A2503 655681 26A2503 697266 26A6667B 417410 26B4610B 412369 26B4610B 419333 26-LP1SF 408438 26-LP1SF 408438 26-LP1SF 414819 26-LP1SF 418497 26-LP1SFDF 583577 26-LP1SFDF 595028 26-LP1SFDF 599316 26-LP1SFDF 617603 26-LP1SFDF 620380 26-LP1SFDF 671133 26-LP2SF 412374 26-LP2SF 417223 26-LP2SF 423100 26-LP2SF 423100 26-LP2SFDF 592704 26-LP2SFDF 617604 26-LP3SF 408287 26-LP3SF 412353 26-LP3SFDF 577939 26-LP3SFDF 605345 26-LP4SF 422101 26-LP6SF 419814 26-LP6SF 424210 27-9386A 376178 27-9386A 408314 27-9386A 418220 27-9386A 419957 27-9386A 424866 27-MY1SF 408933 27-MY1SF 414174 27-MY1SF 418498 27-MY1SF 418498 27-MY1SF 425175 27-MY1SFV 377006 27-MY1SFV 408606 27-MY1SFV 414300 27-MY1SFV 420862 28-2961A 420688 28-2961A 420688 28-6031A 406733 28-6031A 415960 28-6031A 419630 28-AR1SF 419285 28-AR1SF 419285 28-AR1SFDF 622878 29-AM1SF 409729 30-9211A 375848 30-CE11SDF 493928 30-CE11SDF 611690 30-CE11SF 368968 30-CE11SF 416765 30-CE11SF 419288 30-CE16SF 417160 30-CE16SF 419449 30-CE16SF 420023 30-CE18SF 415581 30-CE18SF 418823 30-CE1SF 380540 30-CE1SF 407139 30-CE1SF 417154 30-CE1SF 418979 30-CE1SFDF 611688 30-CE1SFDF 647593 30-CE2SFA 415580 30-CE2SFA 416769 30-CE2SFAF 577940 30-CE2SFAF 622818 30-CE3SFDF 622819 30-CE5CSDF 620854 31-0023A 584755 31-0023A 584755 31-0023A 625263 31-7479 378307 31-7479 380125 31-7479A 413934 31-7479A 422011 31-9456 380294 31-9456 414203 31A0585C 406420 31A0585C 412891 31A0585C 419014 31-BM1SF 380701 31-BM1SF 410506 31-BM1SF 414099 31-BM1SF 414823 31-BM1SFDF 577941 31-BM2SFDF 638298 31-BM4SF 421860 32-4688A 409410 32-ST1SF 410793 32-ST1SF 424971 32-ST1SFDF 582266 32-ST1SFDF 608823…
FDA’s list runs to 24,570 characters. The first part is shown; the rest is on FDA’s record.
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.
Worldwide Distribution - US (Nationwide) and Internationally to Canada
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 1, 2017.
- FDA classified it on Sep 5, 2017.
- FDA’s Enforcement Report published it on Sep 13, 2017.
- FDA terminated it on Jun 18, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cardinal Health 200, LLC, of Waukegan, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
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 24,570 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.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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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.
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.