DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box) (International Dis
FDA device recall Z-1948-2011 · posted 2011-04-12 · Terminated
Recall details
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Reason for recall
- Product sterility may be compromised due to breach in sterile packaging
- Action taken
- Depuy Mitek sent an Urgent Voluntary Product Recall letter dated December 2, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to isolate all inventory of the affected product and call 1-800-382-4682, PROMPT 3, for return good authorization and replacement product. Customers were instructed to return all identified affected product to: DePuy Mitek ATTN: Recall Coordinator 50 Scotland Boulevard Bridgewater, MA 02324 Record their assigned return material authorization (RMA) number on the outer shipping box. Use the Prepaid Federal Express shipping label for the return of the product. Include a photo copy of the completed business reply form. For questions or concerns call 1-800-382-4682, PROMPT 3.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- HBX
- Quantity affected
- 92,000 units (920 boxes/100)
- Distribution
- Worldwide Distribution - USA (nationwide) and the coutnries of United Arab Emirates, Australia, Belgium, Switzerland, Czech, Denmark, France, UK, Italy, Netherlands, Poland, and Slovakia.
- Date initiated
- 2010-12-03
- Date posted
- 2011-04-12
- Date terminated
- 2013-04-02
- Location
- Raynham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT (K951843) | Future Medical Systems, Inc. | 1995-07-14 |