Surgical gloves recalled for incomplete sterile pouch sealing
Ansell Healthcare Products LLC has recalled certain NOVAPLUS GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. Improper sealing could allow contamination before use.
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: This is an FDA Class II medical device recall for a surgical product with potential for contamination if sterile pouches are compromised. No illnesses or injuries have been reported, placing this in the High severity category as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Ansell Healthcare Products LLC is recalling NOVAPLUS GAMMEX NON-LATEX PI GREEN surgical gloves due to incomplete sealing of sterile pouches. The affected gloves have reference numbers V20685255 through V20685290 and are from lot 2203434604, totaling 378 units.
Some sterile pouches were not completely sealed during manufacturing. Incomplete sealing could potentially allow bacterial contamination of the surgical gloves before they are used.
The recalled gloves were distributed nationwide in Indiana, Ohio, New York, Virginia, Illinois, Tennessee, Georgia, South Carolina, Wisconsin, Florida, and Canada.
The recalled product
- Product
- NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
- Manufacturer
- Ansell Healthcare Products LLC
- Category
- Medical Device — Surgical gloves
- Hazard
- contamination-risk
- packaging-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot: 2203434604
- REF/UDI-DI: V20685255/10014566400553
- V20685260/10014566400607
- V20685265/10014566400652
- V20685270/10014566400706
- V20685275/10014566400751
- V20685280/10014566400805
- V20685285/10014566400850
- V20685290/10014566400904.
Distribution
Distributed nationwide across the United States.
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