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Terminated

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

FDA Recall Z-0465-2014 · Posted 2013-12-06

Recalling FirmKarl Storz Endoscopy America Inc
Recall StatusTerminated
Product CodeGCJ
Date Initiated2013-11-06
Date Terminated2014-01-13
Product Quantity7 units

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.

Firm Action

Karl Storz Endosocopy sent a Safety Alert letter dated November 6, 2013, to all customers who received the 33821DYD Axillent Debakey Grasping Forceps. The letter informed the customers of the problems identified and the actions to be taken. Customers were asked to set aside the mislabeled product and return the mislabeled instruments with the RMA (Return Material Authorization) number issued to them. Customers were instructed to fax or email completed recall response form to (424) 218-8519. Customers with any questions were instructed to call (800) 421-0837 ext 8289. For questions regarding this recall call 746-708-8440.

Root Cause

Labeling mix-ups

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K934937KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORCKARL STORZ Endoscopy-America, Inc. · 1994-03-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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