CLASS III Device recall · Reported 17 Apr 2013 · FDA Enforcement Report
LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number recalled
Lighthouse For The Blind is recalling LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011, distributed nationwide in the US. The recall was initiated on 22 Mar 2013 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1090-2013
- FDA event ID
- 64776
- Recalling firm
- Lighthouse For The Blind, Olivette, MO
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Mar 2013
- FDA classified
- 10 Apr 2013
- Reported
- 17 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 22 Mar 2013 | Recall initiated by company | |
| 10 Apr 2013 | Classified by FDA | +19 days |
| 17 Apr 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoDistrict of ColumbiaDelawareFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyMarylandMichiganMinnesotaMissouriMontana
Questions about this recall
Is LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011 recalled?
Yes. Lighthouse For The Blind recalled LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011 on 22 Mar 2013. The recall is Class III and its status is Terminated. Recall number Z-1090-2013.
Why was it recalled?
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
Which lots are affected?
All kits shipped between 1/12010 through 3/4/2013.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Lighthouse For The Blind
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | LHB, First Aid Type I Individual Kit, NSN: 6545 recalled | Lighthouse For The Blind | Sterility | Nationwide |
| Device | CLASS III | LHB, Perishable recalled by Lighthouse For The Blind | Lighthouse For The Blind | Sterility | Nationwide |
| Device | CLASS III | LHB, Perishable Items Pack Type IV recalled by Lighthouse For The Blind | Lighthouse For The Blind | Sterility | Nationwide |
| Device | CLASS III | LHB, Perishable Items Pack Type I , Kit Number recalled | Lighthouse For The Blind | Sterility | Nationwide |
| Device | CLASS III | LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg recalled | Lighthouse For The Blind | Sterility | Nationwide |
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