FDA Device recall Z-0709-2022
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
- FDA Device
- Class II
- ongoing
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class II recall of Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment by Lacrimedics, citing the sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0709-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-17 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Lacrimedics |
| Distribution | US |
Product
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
Reason
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
Identifiers
| code_info | CP3 010421-3358 CP3 031419-3125 CP3 032921-3429 CP3 042020-3284 CP3 052219-3149 CP3 061521-3482 CP3 071720-…CP3 010421-3358 CP3 031419-3125 CP3 032921-3429 CP3 042020-3284 CP3 052219-3149 CP3 061521-3482 CP3 071720-3322 CP3 080218-3045 CP3 091218-3057 CP3 122118-3093 CP4 010621-3377 CP4 022619-3094 CP4 041620-3285 CP4 041719-3126 CP4 072020-3323 CP4 092518-3058 CP5 011221-3359 CP5 033121-3430 CP5 042219-3127 CP5 042220-3286 CP5 072320-3324 CP5 082318-3010 CP5 111418-3059 HP7 103018-3062 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0709-2022%22
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