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Recall Observatory FDA recall evidence

Device product

Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular

Z-2590-2023

August 10, 2023

Class II

Product summary

Firm
ARROW INTERNATIONAL Inc.
Event
Event 92850
Status
Ongoing
Classification
Class II
Quantity
190 units
Official record key
device-enforcement:Z-2590-2023

Official wording

Reason: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

Code information: Batch/Lot number 13F22J0617

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

Field note

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