New York Embroidery Studio Recalls Isolation Gowns for Liquid Barrier Failure
New York Embroidery Studio is recalling 5,400 Trinity Non-Surgical Isolation Gowns because they do not consistently meet minimum liquid-barrier performance requirements.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a failure to meet minimum liquid-barrier performance, which poses a risk of harm to users, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
New York Embroidery Studio, Inc. is recalling 5,400 units of the Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large (Model Number: NYES100-2). The gowns are packaged in inner packs of 10 and 100 per shipping case. The specific lot number is B0676, with UDI-DI 10860008955149.
The recall was initiated because the gowns do not consistently meet the minimum liquid-barrier performance required for their intended use. This defect may compromise the protective function of the gowns in clinical settings.
The affected gowns were distributed nationwide in the state of Connecticut. Healthcare facilities and consumers who have these specific gowns should stop using them and contact the recalling firm for further instructions.
The recalled product
- 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.
- Manufacturer
- New York Embroidery Studio, Inc.
- Hazard
- Affected units
- 5,400
Distribution
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