Z-1510-2018Class II
T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection...
Stryker Corp. / initiated 2018-02-23 / Terminated / root cause: manufacturing process
Stryker Instruments Div. of Stryker Corporation began a recall of T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment on . FDA classified it as Class II and gives the reason as "Separation of material layers may occur, causing a potential risk of exposure to contaminants". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1510-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Corp.
- Product
- T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
- Product code
- FYA Gown, Surgical
- Reason for recall
- Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- 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 [email protected]. 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.
- Quantity in commerce
- 34570 total products
- Distribution
- US Nationwide and Ireland, Japan, South Korea, UK
- Product codes and lots
- Lot numbers: 17061837, 17061859, 17113164
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1500-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1501-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1502-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1503-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1504-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1505-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1506-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1507-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1508-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1509-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1510-2018 | Class II | Terminated | Voluntary: Firm initiated |
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