Non-sterile recall: Labeling Error
Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a…
Why was Non-sterile recalled?
Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner box indicating another size).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item Numbers: size XS - D5061/lot number: AEAM1105/UDI: 00811220035433; size S - D5062/lot number: AEAM1103,AEAM1104,AEAM1105,AEAM1106,AEAN0204,AEAN0205,AEAN0206,AEAN0307,AEAN0308,AEAN0309,AEAN0310,AEAN0311,AEAN0312,AEAN0316,AEAN0317,AEAN0318/ UDI: 00811220035440; size M - D5063/lot number: AEAM1104,AEAM1105,AEAM1112,AEAN0204,AEAN0205,AEAN0206,AEAN0307,AEAN0308,AEAN0309,AEAN0311,AEAN0312,AEAN0316,AEAN0317,AEAN0318,AEAN0319,AEAN0320,AEAN0206/UDI: 00811220035457; size L - D5064/lot number: AEAM1103,AEAM1104,AEAM1106,AEAN0204,AEAN0205,AEAN0206,AEAN0307,AEAN0308,AEAN0309,AEAN0310,AEAN0311,AEAN0312,AEAN0317,AEAN0318,AEAN0319,AEAN0320/UDI: 00811220035464; and size XL D5065/lot number: AEAN0204,AEAN0205,AEAN0206,AEAN0308,AEAN0310,AEAN0311/UDI: 00811220035471
- Product
- Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a…
- Recalling firm
- SVS LLC
- Quantity
- 155,540 inner boxes
- Distribution
- US Nationwide distribution in the states of MI, NE, FL, GA, PA, AR, CO, and NY.
- Recall date
- July 17, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)