FDA recall Z-1510-2018

Stryker Instruments Div. of Stryker Corporation · Class II · device

Product

T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment

Reason for recall

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

Distribution

US Nationwide and Ireland, Japan, South Korea, UK

Key facts

Status
Terminated
Initiation date
2018-02-23
Report date
2018-05-02
Termination date
2019-05-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1510-2018