Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissu
FDA device recall Z-0465-2014 · posted 2013-12-06 · Terminated
Recall details
- Recalling firm
- Karl Storz Endoscopy America Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 7 units
- Distribution
- Nationwide Distribution including states of: TX, PA, and NY.
- Date initiated
- 2013-11-06
- Date posted
- 2013-12-06
- Date terminated
- 2014-01-13
- Location
- Southbridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC (K934937) | KARL STORZ Endoscopy-America, Inc. | 1994-03-23 |