FDA Medical Device Recalls (openFDA)
Lighthouse For The Blind: LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.
- Recall number
- Z-1089-2013
- Recalling firm
- Lighthouse For The Blind
- Product
- LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.
- Status
- Terminated
- Initiated
- 2013-03-22
- Posted
- 2013-04-10
- Terminated
- 2013-11-25
- Reason
- The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili
- Root cause
- Labeling False and Misleading
- Action
- The firm sent "URGENT DEVICE RECALL" letters dated March 22, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 800-542-3697 for questions regarding this notice.
- Quantity
- 1,034 kits
- Distribution
- Nationwide Distribution including DC and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, MI, MD, MN, MO, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA and WY.
- Lot, serial or model codes
- All kits shipped between 1/12010 through 3/4/2013.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRR
- Firm FEI
- 1000118065
- Firm city
- Olivette
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28