Device recall: LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit…
Class III FDA enforcement event 64776. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Lighthouse For The Blind started this device recall on 22 Mar 2013. The firm address in the FDA record is in Olivette, MO. FDA put the recall in Class III. FDA event 64776 has 8 product records. The first FDA enforcement report date is 17 Apr 2013. The record gives the status Terminated, with the termination date 25 Nov 2013.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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.
Recalling firm
Lighthouse For The Blind, Olivette, MO.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
8 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1086-2013 | 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. | 635 kits | Class III | Terminated | 17 Apr 2013 |
| Z-1087-2013 | LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit. | 2,815 kits | Class III | Terminated | 17 Apr 2013 |
| Z-1088-2013 | LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit. | 56,133 kits | Class III | Terminated | 17 Apr 2013 |
| Z-1089-2013 | LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit. | 1,034 kits | Class III | Terminated | 17 Apr 2013 |
| Z-1090-2013 | LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit. | 41,595 kits | Class III | Terminated | 17 Apr 2013 |
| Z-1091-2013 | LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit. | 227 kits | Class III | Terminated | 17 Apr 2013 |
| Z-1092-2013 | LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit. | 6,075/kits | Class III | Terminated | 17 Apr 2013 |
| Z-1093-2013 | LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit. | 425 kits | Class III | Terminated | 17 Apr 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2013
- 1,236
- Share of these events in Class III
- 5%
- Product records in this event
- 8
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-1086-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 64776. https://recallregister.com/fda/iii/64776/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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.
- What quantity of product is in FDA event 64776?
- The event has 8 product records. The first record gives this quantity:
635 kits
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2013 have the same class?
- 5% of the 1,236 device events that started in 2013 are in Class III.