PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for
FDA device recall Z-1527-2014 · posted 2014-04-30 · Terminated
Recall details
- Recalling firm
- Laurimed LLC
- Reason for recall
- The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
- Action taken
- All direct accounts were notified on April 8, 2014 with an Urgent: Medical Device Recall of PolypVac Microdebrider letter, sent by first class mail. The letter identified the affected product, the reason for the recall, and stated that the firm is in the process of implementing corrections. The firm is requesting that all unused lots be returned to them. Replacement devices will sent to customers. In addition, customers are to complete the attached Lot Information sheet. Questions should be directed to bdubois@laurimed.com or 650-587-5296.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- ERL
- Quantity affected
- 58
- Distribution
- Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.
- Date initiated
- 2014-04-07
- Date posted
- 2014-04-30
- Date terminated
- 2014-05-14
- Location
- Redwood City, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LAURIMED POLYPVAC MICRODEBRIDER (K133133) | Laurimed, LLC | 2013-12-23 |