Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a…
Medical device recall Z-0799-2016. Published in FDA’s Enforcement Report on Mar 2, 2016.
- FDA Class I
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 Mar 2, 2016. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 1341 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
1341, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
RPN/Catalog number: C-PMS-250-PED C-PMS-251J-PED C-PMS-300-CHILDRENS-032285 C-PMS-301J-PED C-PMS-301J-PED-BH C-PMS-301-PED C-PMSY-250 C-PMSY-251 C-PMSY-251J C-PMSY-300 C-PMSY-300J C-PMSY-300J-UT-A C-PMSY-300-PED C-PMSY-301J C-PMSY-301J-BH…
Every code shown here, 821 characters
RPN/Catalog number: C-PMS-250-PED C-PMS-251J-PED C-PMS-300-CHILDRENS-032285 C-PMS-301J-PED C-PMS-301J-PED-BH C-PMS-301-PED C-PMSY-250 C-PMSY-251 C-PMSY-251J C-PMSY-300 C-PMSY-300J C-PMSY-300J-UT-A C-PMSY-300-PED C-PMSY-301J C-PMSY-301J-BH C-PMSY-301J-PED C-PMSY-301J-PED-OTP C-PMSY-400-HURLEY-022388 C-PUM-300J C-PUM-301 C-PUM-301J C-PUMY-301J Lots: NS6168054 NS6178118 NS6063352 NS5855441 5824486 5898058 5967405 6079119 NS5932737 NS6028554 NS6042799 NS5922707 NS5932811 NS6145002 5987014 NS6178099 NS6028540 NS5830758 NS5866960 NS5918174 NS5974263 NS6042577 NS6047450 NS6090278 NS6105922 NS6124990 NS5881337 NS5892116 NS6031991 5782006 5855241 NS5881336 NS5892113 NS5945282 6062729 NS5970950 NS6108255 NS6153173 5793198 5925744 6010406 6148800 NS5796483 NS5928602 NS6047451 NS5970942 NS5954223 5945120 NS5954224 5973354
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 including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada
The states and territories these words name
- District of Columbia
- Puerto Rico
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 Jan 6, 2016.
- FDA classified it on Feb 24, 2016.
- FDA’s Enforcement Report published it on Mar 2, 2016.
- FDA terminated it on Aug 23, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cook Inc., of Bloomington, IN.
- 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.