FDA recall Z-0709-2022

Lacrimedics Inc · Class II · device

Product

Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment

Reason for recall

The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

Distribution

Nationwide and Worldwide Distribution to following countries - AR. BE, BO, BR, CH, CN, CO, CZ, DE, EC, ES, FI, GE, IN, IL, MY, MX, NZ, PE, RO, SG, SA, TR, TW, TZ, UK

Key facts

Status
Ongoing
Initiation date
2022-01-17
Report date
2022-03-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dupont, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0709-2022