Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
Recall
- Recall Number
- Z-0709-2022
- Event Number
- 89463
- Firm
- Lacrimedics Inc
- FEI Number
- 2024818
- Product Code
- LZU
- Status
- Open, Classified
- Root Cause
- Packaging process control
- Initiated
- January 17, 2022
- Address
- 2620 Williamson Pl, Ste 113, Dupont, WA, 98327-9518
Description
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
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
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
4780 units