Recall Z-1503-2018— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-1503-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-23

Class II · Terminated

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2018-02-23, terminated 2019-05-23. It names one FDA 510(k) clearance: K070078. Product: T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment. Reason: Separation of material layers may occur, causing a potential risk of exposure to contaminants..

Recalling firm: Stryker Instruments Div. of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-02-23
Terminated: 2019-05-23
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K070078 — STRYKER T4 HYTREL TOGAStryker Instruments, Instruments Div.·cleared 2007-02-02

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

T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment

Reason for recall

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

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