FDA-Device2023-10-11Class IMISBRANDING
Arrow ErgoPack PICC catheter kits recalled for incorrect labeling on packaging
LABEL MIX UPNationwide distribution
Check Arrow ErgoPack PICC catheter kits for labeling errors
Arrow International identified that some Arrow ErgoPack PICC catheter kits (Lot 33F23B0781) have incorrect product codes and names printed on the package label. This labeling error could lead to confusion during clinical use. No injuries have been reported.
- Locate affected kits with Lot number 33F23B0781 and REF CDC-45552-VPS2
- Verify the product code and name on the package label against correct documentation
- Contact Arrow International or your supplier for guidance on affected units
- Do not use kits if the label does not match your expected product
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
1173 units
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2024Don't want to check this manually?
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