Z-1504-2018 Class II Terminated
FDA device recall Z-1504-2018 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 Pullover Toga, X-Large; Catalog Number: 0400-770-000 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: 17061775, 17061781, 17061784, 17061793, 17102891, 17102916, 17102925, 17102995, 17113013, 17113083, 17113190