Recall Z-1612-2023— Stryker Sustainability Solutions

Name: FDA recall Z-1612-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-14

Class II · Ongoing

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2023-04-14. It names one FDA 510(k) clearance: K100909. Product: REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile. Reason: Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged..

Recalling firm: Stryker Sustainability Solutions
Classification: Class II
Status: Ongoing
Initiated: 2023-04-14
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K100909 — REPROCESSED COMPRESSION SLEEVESAscent Healthcare Solutions·cleared 2010-07-23

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

REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile

Reason for recall

Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.

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