Brand Name: Infusor SV and LV Elastomeric Infusion Devices
Medical device recall Z-1600-2013. Published in FDA’s Enforcement Report on Jul 3, 2013.
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 3, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 3,255,096 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?
Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications.
3,255,096 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Codes: 2C1008KP, 2C1009KP, 2C1063KP, 2C1087KP, 2C1156KP, 2C1700KP, 2C1702KP Lot Codes: 10F032 10G056 10H066 10J047 10K024 10K087 10M021 10M088 10F059 10F069 10F070 10G029 10G043 10G062 10G067 10H032 10H093 10J049 10J060 10J089…
Every code shown here, 799 characters
Product Codes: 2C1008KP, 2C1009KP, 2C1063KP, 2C1087KP, 2C1156KP, 2C1700KP, 2C1702KP Lot Codes: 10F032 10G056 10H066 10J047 10K024 10K087 10M021 10M088 10F059 10F069 10F070 10G029 10G043 10G062 10G067 10H032 10H093 10J049 10J060 10J089 10J105 10K028 10K030 10K038 10K088 10K096 10K102 10M025 10M044 10F022 10F068 10F072 10G030 10G045 10G046 10G047 10G050 10G051 10H016 10H018 10H087 10H094 10J053 10J058 10J062 10J102 10K026 10K035 10K039 10K086 10M023 10M040 10M043 10M045 10F020 10F087 10H086 10H095 10J017 10J020 10J056 10J068 10K021 10K029 10K031 10K081 10K105 10M017 10M039 10J052 10K098 10F064 10H044 10K022 10K042 10F024 10F025 10F033 10F055 10F062 10F063 10F065 10H005 10H030 10H042 10J015 10J019 10J061 10J065 10K032 10K037 10K095 10M030 10M087 10M098 10M099 10M100 Expiration Date: 06/30/13
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.
Distributed Nationwide and in Puerto Rico.
The states and territories these words name
- 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.
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 Jun 7, 2013.
- FDA classified it on Jun 27, 2013.
- FDA’s Enforcement Report published it on Jul 3, 2013.
- FDA terminated it on Jun 4, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Baxter Healthcare Corp., of Round Lake, 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.”
- 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.