New York Embroidery Studio, Inc. recalls New York Embroidery Studio Trinity Non-Surgical Isolation Go
See all recalls from New York Embroidery Studio, Inc. →Recalled Product
New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100 gowns per shipping case.
Hazard / Issue
Gowns do not consistently meet the minimum liquid-barrier performance required.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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