Reported Oct 23, 2019 · Terminated
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as…
ICU Medical Inc.
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: ICU Medical Inc · 600 N Field Dr · Lake Forest, IL · 60045-4835
Is this the product you have?
- Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 1 unit per pouch; 48 pouches per case.
- Lot codes and dates
- Product Code118790412
- Lot number (UDI Number)
855505H (2088778700902010887787009023)865135H (2088778700902010887787009023)918695H (2088778700902010887787009023)928085H (2088778700902010887787009023)937325H (2088778700902010887787009023)3864774 (2088778700902010887787009023)3935434 (2088778700902010887787009023)4011065 (2088778700902010887787009023)4088425 (2088778700902010887787009023)
- Amount recalled
- 170,735 units
This recall covers 22 products
The agency filed one notice per product. You are reading one of them; the other 21 are below.
9 more are in the archive.
Where it was sold
Why it was recalled
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
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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