Recall Z-0465-2014 ยท GCJ Laparoscope, General & Plastic Surgery
Karl Storz Endoscopy America Inc
Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.
| Date | Dec 6, 2013 (initiated Nov 6, 2013) |
| Status | Terminated |
| Reason | KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps. |
| Root cause | Labeling mix-ups |
| 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 regardi |
| Quantity | 7 units |
| Distribution | Nationwide Distribution including states of: TX, PA, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934937 | KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC KARL STORZ Endoscopy-America, Inc., Mar 23, 1994 |