Recall Z-2147-2023— Cardinal Health 200, LLC

Name: FDA recall Z-2147-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-16

Class II · Ongoing

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2023-06-16. It names one FDA 510(k) clearance: K961154. Product: NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010. Reason: Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-06-16
Firm location: Waukegan, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K961154 — BAXTER SODIUM ACETATE INFANT HEEL WARMERBaxter Healthcare Corp·cleared 1996-06-06

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

NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010

Reason for recall

Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.

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