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Recall Observatory FDA recall evidence

Device product

5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2

Z-3200-2018

July 17, 2018

Class II

Product summary

Firm
Arrow International Inc
Event
Event 80839
Status
Terminated
Classification
Class II
Quantity
1257 total
Official record key
device-enforcement:Z-3200-2018

Official wording

Reason: 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.

Code information: 23F17K0753, 23F17L0299

Distribution pattern: The products were distributed to the following US states: AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.