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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

SVS LLC: Nitrile Medical Gloves Recalled for Skin Irritation and Tearing Risks

Agency Publication Date: July 9, 2024
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Summary

SVS LLC is recalling approximately 155,540 boxes of non-sterile, blue nitrile medical examination gloves due to reports of skin irritation and the gloves disintegrating when used with certain cleaning solutions. Additionally, some products are mislabeled, where the size listed on the outer box does not match the size of the gloves inside. These defects could lead to skin reactions or a lack of protection against contamination during medical exams. Consumers should contact their healthcare provider or the manufacturer for further instructions and potential refund information.

Risk

The gloves may cause skin irritation upon contact or tear and disintegrate when exposed to cleaning chemicals, which removes the protective barrier between the user and potential contaminants. Mislabeled sizing also increases the risk of gloves tearing if a user unknowingly attempts to wear a size that is too small.

What You Should Do

  1. Identify your gloves by checking the box for the following item and lot numbers: Extra Small (D5061, Lot AEAM1105), Small (D5062, Lots AEAM1103 through AEAN0318), Medium (D5063, Lots AEAM1104 through AEAN0320), Large (D5064, Lots AEAM1103 through AEAN0320), or Extra Large (D5065, Lots AEAN0204 through AEAN0311).
  2. Verify the UDI barcode numbers on the packaging: 00811220035433 (XS), 00811220035440 (S), 00811220035457 (M), 00811220035464 (L), or 00811220035471 (XL).
  3. Confirm if your box is mislabeled by checking if the size printed on the outer box matches the size printed on the individual inner boxes.
  4. Stop using the affected gloves immediately if you experience skin irritation or if the gloves appear to be disintegrating during use.
  5. Contact your healthcare provider if you have experienced any adverse skin reactions while using these gloves.
  6. Contact SVS LLC at their Charlotte, NC headquarters or via the contact method provided in the initial recall email for instructions on returns or replacements.
  7. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer instructions and potential refund

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Nitrile Powder-Free Blue Medical Examination Gloves (Extra Small)
Model / REF:
D5061
UPC Codes:
00811220035433
Lot Numbers:
AEAM1105
Product: Nitrile Powder-Free Blue Medical Examination Gloves (Small)
Model / REF:
D5062
UPC Codes:
00811220035440
Lot Numbers:
AEAM1103
AEAM1104
AEAM1105
AEAM1106
AEAN0204
AEAN0205
AEAN0206
AEAN0307
AEAN0308
AEAN0309
AEAN0310
AEAN0311
AEAN0312
AEAN0316
AEAN0317
AEAN0318
Product: Nitrile Powder-Free Blue Medical Examination Gloves (Medium)
Model / REF:
D5063
UPC Codes:
00811220035457
Lot Numbers:
AEAM1104
AEAM1105
AEAM1112
AEAN0204
AEAN0205
AEAN0206
AEAN0307
AEAN0308
AEAN0309
AEAN0311
AEAN0312
AEAN0316
AEAN0317
AEAN0318
AEAN0319
AEAN0320
Product: Nitrile Powder-Free Blue Medical Examination Gloves (Large)
Model / REF:
D5064
UPC Codes:
00811220035464
Lot Numbers:
AEAM1103
AEAM1104
AEAM1106
AEAN0204
AEAN0205
AEAN0206
AEAN0307
AEAN0308
AEAN0309
AEAN0310
AEAN0311
AEAN0312
AEAN0317
AEAN0318
AEAN0319
AEAN0320
Product: Nitrile Powder-Free Blue Medical Examination Gloves (Extra Large)
Model / REF:
D5065
UPC Codes:
00811220035471
Lot Numbers:
AEAN0204
AEAN0205
AEAN0206
AEAN0308
AEAN0310
AEAN0311

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94769
Status: Active
Manufacturer: SVS LLC
Manufactured In: United States
Units Affected: 155,540 inner boxes
Distributed To: Michigan, Nebraska, Florida, Georgia, Pennsylvania, Arkansas, Colorado, New York

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.