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Recall Observatory FDA recall evidence

Device product

Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.

Z-2034-2021

May 21, 2021

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 88046
Status
Terminated
Classification
Class II
Quantity
13426 units
Official record key
device-enforcement:Z-2034-2021

Official wording

Reason: The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.

Code information: Lot Numbers: 2320DR1, 2330DR1, 2410DR1, 2440DR1, 2450DR1, 2580DR1, 2670DR1, 2730DR1, 2740DR1, 2790DR1, 2830DR1, 2860DR1, 2870DR1, 2890DR1, 2900DR1, 2930DR1, 2940DR1, 2950DR1, 3080DR1, 3310DR1, 3320DR1, 3330DR1, 3350DR1

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.