FDA Device recall Z-1087-2013
LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads
- FDA Device
- Class III
- terminated
- Published 2013-04-17
On 2013-04-17 the FDA classified a Class III recall of LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads 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
| Agency | FDA Device |
|---|---|
| Recall number | Z-1087-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-03-22 |
| Published | 2013-04-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Lighthouse For The Blind |
| Distribution | US |
Product
LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. 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_info | All 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-1087-2013%22
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