OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
- Company
- Lacrimedics Inc
- Recall Initiated
- January 17, 2022
- Recall Number
- Z-0708-2022
- Quantity
- 5767 units
- Firm Location
- Dupont, WA
Reason for Recall
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
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
Lot / Code Info
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
Root Cause
Packaging process control
Action Taken
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