Z-1527-2014 Class III Terminated
FDA device recall Z-1527-2014 was initiated by Laurimed LLC on April 7, 2014 and is designated Class III. Reason for recall: The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle. The recall status is terminated (terminated May 14, 2014). Affected quantity: 58.
Recall Details
- Product Type
- Devices
- Report Date
- May 7, 2014
- Initiation Date
- April 7, 2014
- Termination Date
- May 14, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58
Product Description
PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.
Reason for Recall
The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
Distribution Pattern
Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.
Code Information
Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014.