VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815,
FDA device recall Z-1081-2015 · posted 2015-02-10 · Terminated
Recall details
- Recalling firm
- Lacrimedics Inc
- Reason for recall
- Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon contact. The firm's data also suggests that a 4 year shelf life may not be sustained.
- Action taken
- The firm notified their foreign consignees on 11/26/14. The firm made a decision to conduct a domestic recall on 12/4/14 and will notify US consignees Consignees will be provided with a return label and request any devices that they still have be returned to the firm. Any consignees that have gone out of business will be sent a certified letter to their last known address. CORRECTIVE ACTIONS: The firm has halted sales of the device until the drying method can be improved. Any remaining stock has been placed in quarantine and will be scrapped.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LZU
- Quantity affected
- 781 units
- Distribution
- Worldwide Distribution-US (nationwide) including the states of AR, CA, FL, ID, IL, KS, MA, MI, NC, NJ, NY, OR, PA, and TX and to the countries of Australia, Brazil, Czech Republic, France, Ireland, Me
- Date initiated
- 2014-11-26
- Date posted
- 2015-02-10
- Date terminated
- 2015-03-23
- Location
- DuPont, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST (K140026) | Lacrimedics, Inc. | 2014-06-03 |