Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended
FDA device recall Z-1676-2014 · posted 2014-06-02 · Terminated
Recall details
- Recalling firm
- Aesculap, Inc.
- Reason for recall
- AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.
- Action taken
- Aesculap sent an Important Correction & Removal recall letter dated April 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. An Aesculap Sales Representative will contact you to schedule return of any affected inventory and replace your product. Please complete the attached Inventory Sheet which is necessary to comply with FDA regulations. When completing the inventory sheet, please be sure to fill in the quantity being returned. If you cannot locate the product, please provide an explanation as to why the inventory will not be returned (discarded, etc.). AIC (USA) appreciates your cooperation on this matter and apologizes for the inconvenience this may cause. Thank you for your patience and continued support of this product. Please contact (610) 984-9414 with any questions.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JXG
- Quantity affected
- 48
- Distribution
- US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.
- Date initiated
- 2014-04-21
- Date posted
- 2014-06-02
- Date terminated
- 2014-10-20
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV) (K031303) | Aesculap, Inc. | 2003-06-04 |