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Green Sprouts

O2cool, LLC · Model 222341-921-33 · UDI-DI 00715418174730

KKO

510(k) clearances

Adverse events

Recalls

Facilities

Description

Cool Ring Teether (2 pack) Clear - 6mo+

Recalls

Date	Firm	Reason
2022-12-02	Tomy International Inc.	Affected lots of the product are being recalled due to potential microbial growth in the fluid inside the device. if a compromised product is used by a child with a weakened immune
2009-07-17	Luv N' Care Ltd	Gel filled teethers were found to contain to contain Bacillus circulans and Bacillus subtilis.
2009-07-07	IMTEC Corporation	Size printed on product packaging does not match size of enclosed product.
2006-01-25	RC2 Brands Inc., The First Years	Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
2006-01-25	RC2 Brands Inc., The First Years	Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
2006-01-25	RC2 Brands Inc., The First Years	Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
2006-01-25	RC2 Brands Inc., The First Years	Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
2006-01-25	RC2 Brands Inc., The First Years	Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
2006-01-25	RC2 Brands Inc., The First Years	Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.