FDA-Device2023-10-11Class IMISBRANDING
Arrow ErgoPack Complete Four-Lumen CVC recalled for incorrect product labeling
LABEL MIX UPNationwide distribution
Check Arrow ErgoPack Complete catheter kit labels
Arrow International issued a recall of 180 units of Arrow ErgoPack Complete Four-Lumen central venous catheters (Lot 33F23B0723) because the product code and product name were printed incorrectly on the kit packaging. This labeling error could cause confusion during clinical use.
- Check any Arrow ErgoPack Complete kits (Lot 33F23B0723) in your facility or inventory for incorrect labeling
- Do not use affected kits until you verify the product code and name match the correct specifications
- Contact Arrow International or the FDA MedWatch program with questions or to report issues
Hazard
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Sold states
US
Affected count
180 units
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2024Don't want to check this manually?
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