FDA-Device2018-09-26Class II
5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
Arrow International Inc
Hazard
The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.
Sold states
The products were distributed to the following US states: AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, and WA.
Affected count
1257 total
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3200-2018Don't want to check this manually?
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