Recall Z-1925-2020— Stryker Corporation

Name: FDA recall Z-1925-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-07

Class II · Ongoing

Class II FDA medical device recall by Stryker Corporation, initiated 2020-01-07. It names one FDA 510(k) clearance: K162885. Product: Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282. Reason: Sterile drapes packaged in an unsealed pouch..

Recalling firm: Stryker Corporation
Classification: Class II
Status: Ongoing
Initiated: 2020-01-07
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K162885 — SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc.·cleared 2017-01-11

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

Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282

Reason for recall

Sterile drapes packaged in an unsealed pouch.

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