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U.S. Department of Health and Human Services

Class 2 Device Recall Collagen Plugs (CP)

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  Class 2 Device Recall Collagen Plugs (CP) see related information
Date Initiated by Firm January 17, 2022
Create Date March 01, 2022
Recall Status1 Open3, Classified
Recall Number Z-0709-2022
Recall Event ID 89463
510(K)Number K895342  
Product Classification Plug, punctum - Product Code LZU
Product Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
Code Information 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
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 4780 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.
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