Recall Z-1299-2015— CooperSurgical, Inc.

Name: FDA recall Z-1299-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-26

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2015-01-26, terminated 2016-06-14. It names one FDA 510(k) clearance: K912715. Product: Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide gentle heat to increase blood flow and enhance infant blood sample collection. Reason: Products without expiration date have the remote potential for minor burn.

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-01-26
Terminated: 2016-06-14
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K912715 — INSTANT WARM GEL PACKPrism Technologies, Inc.·cleared 1991-10-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide gentle heat to increase blood flow and enhance infant blood sample collection

Reason for recall

Products without expiration date have the remote potential for minor burn

Data sourced from openFDA. This site is unofficial and independent of the FDA.