Z-1509-2018 Class II Terminated
FDA device recall Z-1509-2018 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
T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 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: 17061835, 17061838, 17061857, 17071891, 17071904, 17071928, 17102898, 17102943, 17102957, 17102972, 17111362, 17113014, 17113022, 17113038, 17113080, 17113140, 17113205, 17113223