RecallRadar

FDA Device recall Z-1086-2013

LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette

On 2013-04-17 the FDA classified a Class III recall of LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette by Lighthouse For The Blind, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1086-2013
ClassificationClass III
Statusterminated
Initiated2013-03-22
Published2013-04-17
Last updated2026-09-13 11:53 UTC
CompanyLighthouse For The Blind
DistributionUS

Product

LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.

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

Identifiers

code_infoAll kits shipped between 1/12010 through 3/4/2013.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1086-2013%22

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