PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: March 9, 2022 Initiated: January 17, 2022 #Z-0709-2022

Product Description

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.

Details

Recalling Firm
Lacrimedics Inc
Units Affected
4780 units
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
Location
Dupont, WA

Frequently Asked Questions

What product was recalled?
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment. Recalled by Lacrimedics Inc. Units affected: 4780 units.
Why was this product recalled?
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 9, 2022. Severity: Moderate. Recall number: Z-0709-2022.