Z-0465-2014 Class II Terminated
FDA device recall Z-0465-2014 was initiated by Karl Storz Endoscopy America Inc on November 6, 2013 and is designated Class II. Reason for recall: KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps. The recall status is terminated (terminated January 13, 2014). Affected quantity: 7 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2013
- Initiation Date
- November 6, 2013
- Termination Date
- January 13, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
Product Description
Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.
Reason for Recall
KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps.
Distribution Pattern
Nationwide Distribution including states of: TX, PA, and NY.
Code Information
Lot Code YX