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Recall Observatory FDA recall evidence

Device product

Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.

Z-0465-2014

November 06, 2013

Class II

Product summary

Firm
Karl Storz Endoscopy America Inc
Event
Event 66823
Status
Terminated
Classification
Class II
Quantity
7 units
Official record key
device-enforcement:Z-0465-2014

Official wording

Reason: KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps.

Code information: Lot Code YX

Distribution pattern: Nationwide Distribution including states of: TX, PA, and NY.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled