Reported Jul 3, 2013 · Terminated
Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration of medications.
Baxter Healthcare Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corp. · Route 120 And Wilson Rd · Round Lake, IL · 60073-9799
Is this the product you have?
- Brand NameSV Elastomeric Infusion Device. Indicated for the intravenous administration of medications
- Lot codes and dates
- Product Codes
2C1071KJP2C1073KJP2C1075KJP
- Lot Codes09(018 09C023 09(024 09C045 09C047 09(075
08J07808K00208K00508K00708K05408K06608M00108M02508M02808M03908N00308N00508N03209A00409A04009A04209A06498025980279802898070
217 of 217 codes
90029900319003390065900699008609E02609E02709E03109F02309F02409F02509F04009F04109F04209G01309G06109G06209H00409H00809H03509H03609H07009H08209J00609J00709J07409J07509K01709K01809K02109K02209K08609K08709M00209M00509M03709M03809M03909M07809N02709N02809N02909N03410A01910A02010A02110A04410801010802910C00210C00310C00610C07810C07910C09910C10310C111100026100027
- Expiration Dates
06/30/1312/31/1312/31/1406/30/1412/31/1406/30/1512/31/1506/30/15
- Product Codes
- Amount recalled
- 3,255,096 total
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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