CustomEyes kits recalled due to potential sterility compromise
Beaver Visitec International is recalling 4640 units of CustomEyes kits because packaging may contain open seals that could compromise product sterility. Affected units were distributed to 26 U.S. states and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a medical device with potential sterility compromise from open seals. No illnesses or injuries have been reported, fitting the 'risk-of-harm products where injury has not yet been reported' criterion for High severity.
Plain-English summary
Beaver Visitec International, Inc. is recalling 4640 units of CustomEyes kits due to packaging that may contain open seals, potentially compromising product sterility.
The affected products were distributed to 26 U.S. states (AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA, WI) as well as to Canada, Japan, and South Africa. Affected lot numbers include 6051841, 6052299, 6051842, and 6052300 (Catalog #BVI-58001086 and BVI-58001089; UDI/DI 50886158021990 and 50886158021969).
Consumers with affected units should discontinue use and contact Beaver Visitec International for further instructions. Open or compromised packaging on medical devices can compromise product sterility and safety.
The recalled product
- Product
- CustomEyes kits
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device
- Hazard
- open-seals
- sterility-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Catalog #BVI-58001086 and BVI-58001089
- Lot Numbers 6051841
- 6052299
- 6051842
- 6052300 UDI/DI: 50886158021990 and 50886158021969
Distribution
Distributed in 27 states:
- AL
- CA
- CO
- DC
- FL
- GA
- IL
- LA
- MD
- MN
- MT
- NC
- NH
- NJ
- NM
- NY
- OH
- OK
- PA
- RI
- TN
- TX
- UT
- VA
- VT
- WA
- WI
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