Brand Name: SV Elastomeric Infusion Device
Medical device recall Z-1605-2013. 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: SV Elastomeric Infusion Device. 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: 2C1071KJP, 2C1073KJP, 2C1075KJP Lot Codes: 08J078 08K002 08K005 08K007 08K054 08K066 08M001 08M025 08M028 08M039 08N003 08N005 08N032 09A004 09A040 09A042 09A064 98025 98027 98028 98070 09(018 09C023 09(024 09C045 09C047…
Every code shown here, 1,842 characters
Product Codes: 2C1071KJP, 2C1073KJP, 2C1075KJP Lot Codes: 08J078 08K002 08K005 08K007 08K054 08K066 08M001 08M025 08M028 08M039 08N003 08N005 08N032 09A004 09A040 09A042 09A064 98025 98027 98028 98070 09(018 09C023 09(024 09C045 09C047 09(075 90029 90031 90033 90065 90069 90086 09E026 09E027 09E031 09F023 09F024 09F025 09F040 09F041 09F042 09G013 09G061 09G062 09H004 09H008 09H035 09H036 09H070 09H082 09J006 09J007 09J074 09J075 09K017 09K018 09K021 09K022 09K086 09K087 09M002 09M005 09M037 09M038 09M039 09M078 09N027 09N028 09N029 09N034 10A019 10A020 10A021 10A044 108010 108029 10C002 10C003 10C006 10C078 10C079 10C099 10C103 10C111 100026 100027 100028 100058 100062 100063 10E003 10E008 10E009 10E067 10G005 10G006 10G007 10G008 10G078 10G079 10H014 10H019 10H020 10H022 10H054 10H056 10H057 10H060 10H069 10H071 10H105 10H107 10J022 10J023 10J026 10J028 10J029 10J070 10J071 10J074 10K043 10K044 10K047 10K049 10K051 10K061 10K065 10K110 10M056 10M058 10M059 10M060 10N006 10N024 10N028 10N078 11A022 11A024 11A030 11A052 11A074 11A075 08K001 08K003 08K053 08K077 08M002 08N007 08N029 08N030 08N034 08N069 08N070 09A001 09A063 98026 98069 98071 09C046 90025 90032 90070 09E030 09F022 09F026 09G010 09H005 09H037 09J005 09J042 09J043 09J044 09J045 09J089 09K020 09K050 09M001 09M041 09N032 09N041 10A017 10A022 10A046 108014 108024 10C076 10C100 10C102 100025 100029 10E002 10E007 10E045 10E055 10G001 10G003 10G004 10H024 10H058 10H059 10H072 10J021 10J024 10J027 10J072 10K046 10K048 10K063 10K064 10M034 10M057 10N023 10N077 11A023 11A031 11A054 08K067 08M003 09A006 98078 90026 90085 09E052 09H001 09J071 09K053 09M003 09M077 108025 10C005 10C080 10C101 100059 10E053 10H023 10H106 10J030 10J045 10J069 10K066 10M086 10N027 11A025 Expiration Dates: 06/30/13, 12/31/13, 12/31/14, 06/30/14, 12/31/14, 06/30/15,12/31/15, 06/30/15
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
-
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.