FDA-Device2019-10-16Class II
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access
Arrow International Inc
Hazard
Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.
Sold states
US Nationwide Distribution
Affected count
3,143
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0053-2020Don't want to check this manually?
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