Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : Cooper

FDA device recall Z-2147-2015 · posted 2015-07-20 · Terminated

Recall details

Recalling firm

CooperSurgical, Inc.

Reason for recall

Product marketed without a 510(k)

Action taken

CooperSurgical sent an " Urgent WarmGel Infant Heel Warmer" letter dated June 30, 2015, FEDEx, confirmed delivery receipt on July 6, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. CooperSurgical is advising all WarmGel users to review your inventory of this product, remove it from your inventory and discontinue its use. informing them of the reason to cease using the product and either discard or return product to CooperSurgical. Accounts are provided with a response form to complete. Any questions contact CooperSurgical at 203 601 5200 Ext. 310

Root cause

No Marketing Application

Status

Terminated

Product code

MPO

Quantity affected

6,344,700

Distribution

Worldwide Distribution - Nationwide Distribution and to the countries of : AUSTRALIA, BERMUDA, ECUADOR , FRANCE, NEW ZEALAND, SAUDI ARABIA and UNITED KINGDOM.

Date initiated

2015-07-06

Date posted

2015-07-20

Date terminated

2016-06-14

Location

Trumbull, CT