Recall Z-0465-2014— Karl Storz Endoscopy America Inc

Name: FDA recall Z-0465-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-06

Class II · Terminated

Class II FDA medical device recall by Karl Storz Endoscopy America Inc, initiated 2013-11-06, terminated 2014-01-13. It names one FDA 510(k) clearance: K934937. Product: Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.. Reason: KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps..

Recalling firm: Karl Storz Endoscopy America Inc
Classification: Class II
Status: Terminated
Initiated: 2013-11-06
Terminated: 2014-01-13
Firm location: Southbridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K934937 — KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORCKARL STORZ Endoscopy-America, Inc.·cleared 1994-03-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.