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Moi-Stir oral swabsticks, an aid to mouth care and oral hygiene, CONTENTS: 3 fibre-tipped swabsticks premoistened with M

FDA device recall Z-0820-05 · posted 2005-05-11 · Terminated

Recall details

Recalling firm
Kingswood Laboratories,Inc
Reason for recall
Contaminated with Aspergillus and Penicillum molds.
Action taken
The firm issued a press release on 4/22/05 instructing consumers to not use the product and to return it to them. Consignees were notified via letter dated 4/22/05.
Root cause
Other
Status
Terminated
Product code
LFD
Quantity affected
3026 cases
Distribution
Nationwide.
Date initiated
2005-04-22
Date posted
2005-05-11
Date terminated
2005-09-30
Location
Indianapolis, IN

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Related 510(k) clearances

RecordFirmDate
MOI-STIR ORAL SWABSTICK(S) (K851026)Kingswood Laboratories, Inc.1985-05-21