Lacrimedics Inc Recall 89463
Description: Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
Lacrimedics Inc Recall 89463 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0709-2022 |
| Event ID | 89463 |
| Event Description | Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment |
| Product Type | Devices |
| 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 |
| Quantity | 4780 units |
| Recall Reason | The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility. |
| Device Classification | 20220309 |
| Device Code Info | 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 |
| Center Classification Date | 20220301 |
| Recall Initiation Date | 20220117 |
| Recalling Firm | Lacrimedics Inc |
| Initial Notification | Letter |
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