FDA-Device2018-02-21Class II
ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
Arrow International Inc
Hazard
Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.
Sold states
US nationwide distribution.
Affected count
2691 total
Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0602-2018Don't want to check this manually?
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