DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for F
FDA device recall Z-0191-2014 · posted 2013-11-08 · Terminated
Recall details
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Reason for recall
- Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination
- Action taken
- DePuy Mitek inititaed telephone notification on Ausgust 29, 2013 and sent an Urgent Voluntary Product Recall letter dated September 5, 2013 to US and OUS affected customers/affiliates. The customers were notified of the affected products, problem and actions to be taken. The customers were instructed to immediately check all inventories to locate and return affected product following the enclosed instructions. Stericycle is cooridianting the returns. If you have any questions or concerns in regards to this recall, please contact Stericycle directly at 1-866-737-1928.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 368 pk
- Distribution
- Worldwide Distribution - USA (Nationwide) and in the countries of: Australia , Austria , Belgium , Canada , Czech Republic , Denmark , Finland , France, Germany , India, Ireland , Israel, Italy , Latv
- Date initiated
- 2013-08-29
- Date posted
- 2013-11-08
- Date terminated
- 2016-05-12
- 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 |