SafeStep Huber Needle Set Port Access Kit
Medical device recall Z-2666-2020. Published in FDA’s Enforcement Report on Jul 29, 2020.
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 Jul 29, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 5,296,132 total 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?
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 00801741085529), PA-0031YN (UDI 00801741085536), PA-0032 (UDI 00801741085543), PA-0032YN (UDI 00801741085550), PA-0033 (UDI 00801741085567), PA-0033YN (UDI 00801741085574), PA-0034 (UDI 00801741085581), PA-0034YN (UDI 00801741085598), PA-0036 (UDI 00801741085604), PA-0038 (UDI 00801741085628), PA-0038YN (UDI 00801741085635)
5,296,132 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 00801741085529), PA-0031YN (UDI 00801741085536), PA-0032 (UDI 00801741085543),…
Every code shown here, 1,716 characters
Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 00801741085529), PA-0031YN (UDI 00801741085536), PA-0032 (UDI 00801741085543), PA-0032YN (UDI 00801741085550), PA-0033 (UDI 00801741085567), PA-0033YN (UDI 00801741085574), PA-0034 (UDI 00801741085581), PA-0034YN (UDI 00801741085598), PA-0036 (UDI 00801741085604), PA-0038 (UDI 00801741085628), PA-0038YN (UDI 00801741085635). Lot Numbers: REDX2834 REDX4856 REDY1792 REDY2773 REEN2075 REEN4559 REEP1004 REEP3058 REEQ4021 REER0466 REER1235 REER2399 REDW3688 REDZ3026 REEN1109 REEP2916 REEQ2690 REEQ4063 REDS1399 REDS1875 REDS3371 REDS4425 REDT1836 REDU4512 REDX2861 REDY0778 REDY3542 REDZ3102 REEN1044 REEP3066 REEQ2648 REER2400 REDR1897 REDR2695 REDR2796 REDS1288 REDS1400 REDS2408 REDS4621 REDT0697 REDT1645 REDT1837 REDT2924 REDT4207 REDU2262 REDU2347 REDU3328 REDV1094 REDV1239 REDV2772 REDV2983 REDW0413 REDX3752 REDY1723 REDY3731 REDZ0146 REDZ1859 REDZ3027 REEN2076 REEN2144 REEN3136 REEP0964 REER2366 REER2367 REER2401 REDN3937 REDQ0732 REDQ1532 REDQ3957 REDS1850 REDS2265 REDT0698 REDT1646 REDT2747 REDT4188 REDU0781 REDU2263 REDV2200 REDV3476 REDW0549 REDX1497 REDX3753 REDZ1056 REDZ1761 REEN1110 REEN2794 REEN4560 REEP3956 REDY3732 REDZ1860 REEN2774 REEN4491 REEP1005 REEQ1672 REER1236 REDQ1535 REDR2696 REDR2795 REDS1857 REDS4422 REDT1838 REDT2744 REDZ1762 REEN1045 REEN2786 REEN4561 REEP2919 REEP4051 REEQ4065 REER1273 REDX0146 REDY0779 REEN2792 REEP0965 REDZ3028 REEN4492 REEP0983 REEQ0701 REEQ1660 REEQ4024 REER0454 REDW1196 REDY0780 REDZ3104 REER2354 REDX1373 REEP0984 REEQ4066 REER2388 REEN1048 REEN2077 REEQ0671 REDX1374 REDZ1065 REEN4562 REEP0942
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
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Jun 19, 2020.
- FDA classified it on Jul 18, 2020.
- FDA’s Enforcement Report published it on Jul 29, 2020.
- FDA terminated it on Jul 29, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Becton Dickinson & Company, of Franklin Lakes, NJ.
- 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.”
- 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.