Reported Jul 3, 2013 · Terminated
Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion…
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 NameCoiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric
- Infusion Device Device ListingD020871 Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate
- Lot codes and dates
- Product Code2C1073KJP
- Lot Numbers
08M00208N00708N02908N03008N03408N06908N07009A001
- Amount recalled
- 601,230 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
Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.
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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