Z-0709-2022Class II

Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment

Name: Z-0709-2022 Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
Creator: Lacrimedics Inc
Published: 2022-01-17
License: https://open.fda.gov/license/

Lacrimedics, Inc. / initiated 2022-01-17 / Open, Classified / root cause: packaging

FDA source

Lacrimedics Inc began a recall of Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment on 2022-01-17. FDA classified it as Class II and gives the reason as "The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0709-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-17
Posted: 2022-03-01
Recalling firm: Lacrimedics, Inc.
Product: Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
Product code: LZU Plug, Punctum
Reason for recall: The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
Root cause tag: packaging
FDA 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 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
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0709-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0708-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-09	2022-03-01
Z-0709-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-09	2022-03-01

Product code LZU

K895342UnclassifiedCollagen Implants for the Lacrimal Efficiency TestLacrimedics, Inc. / cleared 1989-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)