Recall Z-1090-2013— Lighthouse For The Blind
Class III · Terminated
Class III FDA medical device recall by Lighthouse For The Blind, initiated 2013-03-22, terminated 2013-11-25. FDA's recall record names no specific 510(k) clearance for this event. Product: LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. 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.
- Recalling firm
- Lighthouse For The Blind
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-03-22
- Terminated
- 2013-11-25
- Firm location
- Olivette, MO, United States
Product description
LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.
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
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