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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 06, 2014
Date Posted April 01, 2014
Recall Status1 Terminated 3 on April 23, 2015
Recall Number Z-1313-2014
Recall Event ID 67582
Product Classification Ring, Teething, Non-Fluid Filled - Product Code MEF
Product Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teether Coco the Monkey". Non-Fluid Filled Teething Ring.
Code Information Model # 206-647. All lot numbers are included in the scope of the recall 
Recalling Firm/
Manufacturer		 Infantino LLC
4920 Carroll Canyon Rd Ste 200
San Diego CA 92121-3735
For Additional Information Contact
858-875-7220
Manufacturer Reason
for Recall		 Infantino initiated this voluntary recall of all lots of Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teethe Coco the Monkey", Model Number 206-647, because the tail of the monkey may pose a choking hazard to young children.
FDA Determined
Cause 2		 Other
Action Infantino, LLC initiated this recall by notifying its customer on January 6, 2014 and Consumer Product Safety Commission (CPSC) posted the press release on 02/20/2014. CPSC posted the press release on the CPSC website. The CPSC recall press release dated February 20, 2014 informed consumers should stop using this product unless otherwise instructed and it is illegal to resell or attempt to resell a recalled consumer product. The CPSC press release contains a Recall Summary with the name of product, hazard, remedy, consumer contact information "Infantino toll-free at (888) 808-3111 between 8 a.m. and 4 p.m. PT Monday through Friday or online at www.infantino.com and click on Recall Information on the home page.", Recall Details on the number of units, description, incidents/injuries, remedy, sold exclusively at Target stores nationwide, Importer, Manufactured in China, and CPSC Consumer Information Hotline and Media Contact. The CPSC press release also contained photos of the product. Infantino, LLC also posted on their company website information on this recall.
Quantity in Commerce 144,000 units
Distribution US nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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