Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall OPAQUE HERRICK LACRIMAL PLUG (HP)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall OPAQUE HERRICK LACRIMAL PLUG (HP) see related information
Date Initiated by Firm January 17, 2022
Create Date March 01, 2022
Recall Status1 Open3, Classified
Recall Number Z-0708-2022
Recall Event ID 89463
510(K)Number K021831  
Product Classification Plug, punctum - Product Code LZU
Product OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
Code Information HP3 010819-3104 HP3 011321-3373 HP3 031519-3128 HP3 032521-3426 HP3 051419-3157 HP3 073118-3044 HP3 090921-3516 HP3 102618-3060 HP5 011221-3374 HP5 012519-3088 HP5 032019-3123 HP5 032621-3425 HP5 051519-3158 HP5 062521-3489 HP5 070819-3186 HP5 072221-3501 HP5 083018-3036 HP5 102918-3061 HP5 122120-3368 HP7 030821-3404 HP7 032119-3124 HP7 092019-3135 HP7 103018-3062
Recalling Firm/
Manufacturer		 Lacrimedics Inc
2620 Williamson Pl Ste 113
Dupont WA 98327-9518
For Additional Information Contact
253-964-0360
Manufacturer Reason
for Recall		 The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
FDA Determined
Cause 2		 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 for replacement. (distributors) " Acknowledge recall by returning the Recall Response Form to Tanya Traband: TTraband@lacrimedics.com 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 TTraband@lacrimedics.com 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
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LZU and Original Applicant = LACRIMEDICS, INC.
-
-