Recall Z-1547-2022— Family Dollar Stores, Llc.

Name: FDA recall Z-1547-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-23

Class II · Ongoing

Class II FDA medical device recall by Family Dollar Stores, Llc., initiated 2022-06-23. It names one FDA 510(k) clearance: K201186. Product: KY JELLY LUBRICANT 2 FL OZ, SKU 901443. Reason: Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022..

Recalling firm: Family Dollar Stores, Llc.
Classification: Class II
Status: Ongoing
Initiated: 2022-06-23
Firm location: Chesapeake, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K201186 — KY Grosz JellyRb Health (Us), LLC·cleared 2020-07-30

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

KY JELLY LUBRICANT 2 FL OZ, SKU 901443

Reason for recall

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

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