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Recall Observatory FDA recall evidence

Device product

T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment

Z-1506-2018

February 23, 2018

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 79779
Status
Terminated
Classification
Class II
Quantity
34570 total products
Official record key
device-enforcement:Z-1506-2018

Official wording

Reason: Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Code information: Lot numbers: 17061810, 17061814, 17071878, 17071903, 17071918, 17071920, 17071949, 17071960, 17071970, 17071974, 17071997, 17072002, 17072006, 17072016, 17102897, 17102926, 17102936, 17102942, 17102956, 17102971, 17102994, 17102996, 17113021, 17113034, 17113037, 17113084, 17113133, 17113191, 17113197, 17113203, 17113221

Distribution pattern: US Nationwide and Ireland, Japan, South Korea, UK

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Separation of material layers may occur, causing a potential risk of exposure to contaminants.