Results 1 to 1 of 1
04-18-2013, 02:52 PM #1
- Join Date
- Aug 2012
- Merced, CA 95348-1422
- Blog Entries
LHB First Aid Kits / Components - Seven Additional Related Recalls
There were a total of eight recalls listed for Lighthouse for the Blind. All of these recalls are related to confusing labeling / mislabeling related to a Povidine Swab & Ampule - so all are being recalled for the same reason, have the same contact information. Only the recall numbers, product descriptions, and product numbers differ.
The following recalls contain 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 sterilized. Some product labeling states "Sterility guaranteed unless seal broken" or "Contents sterile if package is intact." These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims.
The following recalls cover: All kits shipped between 1/12010 through 3/4/2013.
These are Class III Recalls (a situation in which use of or exposure to a recalled product is not likely to cause adverse health consequences).
These are firm initiated voluntary recalls by Lighthouse for the Blind, Olivette, MO, USA
The original recall date was 3-22-2013 and this is an ongoing recall of products distributed nationwide; 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.
Product Description LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.
Recall Number Z-1087-2013
Product Description LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.
Recall Number Z-1088-2013
Product Description LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.
Recall Number Z-1089-2013
Product Description LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.
Recall Number Z-1090-2013
Product Description LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.
Recall Number Z-1091-2013
Product Description LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.
Recall Number Z-1092-2013
Product Description LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.
Recall Number Z-1093-2013