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Terminated

Gel Filled Teethers, various shapes and sizes, marketed under the names: Nuby, Cottontails, and Playskool. This product is intended for use by infants for medical purposes to soothe gums during the teething process.

FDA Recall Z-1878-2009 · Posted 2009-08-12

Recalling FirmLuv N' Care Ltd
Recall StatusTerminated
Product CodeKKO
Date Initiated2009-07-17
Date Terminated2013-02-28
Product Quantity546,320 units

Reason for Recall

Gel filled teethers were found to contain to contain Bacillus circulans and Bacillus subtilis.

Firm Action

The firm initiated their recall by telephone and email, and followed with letters to their consignees directing a recall to the consumer level. Consumers are urged to stop using the affected product and discard or return to the place of purchase. Consumers with questions about the recall may contact Luv N' Care, LTD by calling 1-800-256-2399. The firm issued a Press Release on July 17, 2009. Press Release about this recall is located on the website address: http://www.fda.gov/Safety/Recalls/ucm172689.htm.

Root Cause

PMA

Distribution Pattern

Worldwide Distribution -- US (states of NY, IA, WI, IL, FL, NE, OH, MI, TX, NY, RI, and VA), Canada, Haiti, West Indies, Surinam, Antilles, Uruguay, Mexico, Bermuda, Canada, Dominican Republic, Dutch West Indies, Bahamas, North Antilles and Paraguay.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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