Recall Z-0877-2015
Perouse Medical · initiated October 6, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter
Codes / lots: Batch numbers: 4041354/4062650/4072586
Reason for recall
Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
FDA-determined cause: Device Design
Action taken
Perouse Medical notified Distributors by Safety Alert Letter sent on October 06, 2014 and and October 07, 2014 by e-mail. The letter identified the defective products and lot numbers and provided a description of the malfunction, risk and mitigation statements. US distributors have been requested to provide the required information to their customers. In addition, the firm has updated device instructions for use. The firm is requiring its customer to fill out a safety notice acknowledgement of receipt form.
Details
- Recall number
- Z-0877-2015
- Initiated
- October 6, 2014
- Posted by FDA
- December 29, 2014
- Terminated
- March 24, 2017
- Product code
- MAV – Syringe, Balloon Inflation
- Quantity
- 2184 units
- Distribution
- US Nationwide Distribution in the states of AZ and CO.
- Recalling firm
- Perouse Medical, Ivry Le Temple
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0876-2015 Class II | Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use…Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase… | 10/06/2014Terminated |