Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
FDA Recall Z-0709-2022 · Posted None
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Recalling FirmLacrimedics Inc
Recall StatusOpen, Classified
Product CodeLZU
Date Initiated2022-01-17
Product Quantity4780 units
Reason for Recall
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
Firm 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 for replacement. (distributors)
" Acknowledge recall by returning the Recall Response Form to Tanya Traband:
[email protected] or
FAX: (253) 964-2699 or Lacrimedics, Inc.
2620 Williamson Place, Suite 113 DuPont, WA 98327
Other information:
Contact Tanya Traband, Manager Client Relationships, at [email protected] or +1.800.367.8327 Ex. 200 Monday through Friday 8:30 a.m. to 4:00 p.m. PST.
" Direct customers are instructed to return product for replacement; prepaid UPS labels are sent with the letter for this purpose
Root Cause
Packaging process control
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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