Z-1507-2018 Class II Terminated
FDA device recall Z-1507-2018 was initiated by Stryker Instruments Div. of Stryker Corporation on February 23, 2018 and is designated Class II. Reason for recall: Separation of material layers may occur, causing a potential risk of exposure to contaminants. The recall status is terminated (terminated May 23, 2019). Affected quantity: 34570 total products.
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- February 23, 2018
- Termination Date
- May 23, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34570 total products
Product Description
T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment
Reason for Recall
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Distribution Pattern
US Nationwide and Ireland, Japan, South Korea, UK
Code Information
Lot numbers: 17061816, 17061836, 17061839, 17061853, 17071921, 17072017, 17102944, 17102948, 17113081, 17113141, 17113194