Recall Z-0708-2022 ยท LZU Plug, Punctum
Lacrimedics Inc
OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
| Date | Jan 17, 2022 |
| Status | Open, Classified |
| Reason | The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility. |
| Root cause | Packaging process control |
| Action | Urgent : Medical Device Recall, Collagen Plugs and Opaque Herrick Lacrimal Plugs customer letters, dated January 17, 2022 and Urgent : Medical Device Recall, Collagen Plugs and Opaque Herrick Lacrimal Plugs distributor letters, dated January 17, 2022 sent starting 1/24/2022 (through 1/28/2022 US and 2/4/2022 (OUS)) via USPS certified letter with return receipt; Distributors and customers are instructed in letter to discontinue distribution and/or use and return remaining product for replacement " Contact their customers regarding the product(s) and request the return of remaining product fo |
| Quantity | 5767 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021831 | OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB Lacrimedics, Inc., Jul 1, 2002 |