Z-1091-2013Class III

LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit

Name: Z-1091-2013 LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit
Creator: Lighthouse For The Blind
Published: 2013-03-22
License: https://open.fda.gov/license/

Lighthouse for the Blind / initiated 2013-03-22 / Terminated / root cause: labeling and UDI

FDA source

Lighthouse For The Blind began a recall of LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit on 2013-03-22. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1091-2013
Classification: Class III
Status: Terminated
Initiated: 2013-03-22
Posted: 2013-04-10
Terminated: 2013-11-25
Recalling firm: Lighthouse for the Blind
Product: LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.
Product code: LRR First Aid Kit With Drug
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 227 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.
Product codes and lots: All kits shipped between 1/12010 through 3/4/2013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1091-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1086-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-10
Z-1087-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-10
Z-1088-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-10
Z-1089-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-10
Z-1090-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-10
Z-1091-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-10
Z-1092-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-10
Z-1093-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-10

Product code LRR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)