T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment
This recall has been terminated (originally issued February 23, 2018).
- Recall Initiated
- February 23, 2018
- Terminated
- May 23, 2019
- Recall Number
- Z-1507-2018
- Quantity
- 34570 total products
- Firm Location
- Portage, MI
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot numbers: 17061816, 17061836, 17061839, 17061853, 17071921, 17072017, 17102944, 17102948, 17113081, 17113141, 17113194
Root Cause
Nonconforming Material/Component
Action Taken
On March 7, 2018 Stryker Instruments mailed Urgent Medical Device Recall Notifications to affected customers. Distributors and Sales Representative were notified via e-mail. Customers were instructed to: 1) Immediately review this Recall Notification; 2) Immediately check all stock areas and/or operating room storage for affected products. Quarantine and discontinue use of any affected T4 and T5 Togas; 3) Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Fax the completed BRF to Stryker Instruments at 866-521-2762, or email to kara.spath@stryker.com. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification; 4) If you have further distributed this product, please forward this Notification and the attached BRF to all affected locations. Please indicate each location on the BRF; 5) If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you and should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. Customer with questions or concerns may call (800)253-3210.