Recall Z-1530-2022— Family Dollar Stores, Llc.

Name: FDA recall Z-1530-2022
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: K160399. Product: SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415. 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

K160399 — Skyn Original Polyisoprene Lubricated Male CondomAnsell Healthcare Products, LLC·cleared 2016-07-25

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

SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415

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.