Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot numbers/Expiration dates: 62743 8/18/2013 57375 9/5/2013 58352 9/13/2013 58985 1/28/2014 62106 7/14/2014 61743 7/21/2014 63397 12/21/2014 63273 12/26/2014 64371 3/13/2015 64329 3/21/2015 66935 4/22/2015 67471 5/11/2015 68296 9/19/2015 68614 9/27/2015 68614 9/27/2015 70876 10/12/2015 69816 10/14/2015 70681 10/20/2015 71211 10/21/2015 71695 10/26/2015 73064 12/20/2015 72359 12/24/2015 77377 1/19/2016 76155 1/25/2016 81170 7/8/2016
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Windstone Medical Packaging, Inc.
- Reason for Recall:
- The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room
Product Codes/Lot Numbers:
Lot numbers/Expiration dates: 62743 8/18/2013 57375 9/5/2013 58352 9/13/2013 58985 1/28/2014 62106 7/14/2014 61743 7/21/2014 63397 12/21/2014 63273 12/26/2014 64371 3/13/2015 64329 3/21/2015 66935 4/22/2015 67471 5/11/2015 68296 9/19/2015 68614 9/27/2015 68614 9/27/2015 70876 10/12/2015 69816 10/14/2015 70681 10/20/2015 71211 10/21/2015 71695 10/26/2015 73064 12/20/2015 72359 12/24/2015 77377 1/19/2016 76155 1/25/2016 81170 7/8/2016
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0164-2017
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Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
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