Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor Pack, part number PSS3541(A
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot number and expiration date 100188, 10/19/2019 100884, 9/17/2019 84683, 5/27/2018 85122, 6/3/2018 85476, 8/17/2018 85717, 7/21/2018 86693, 9/3/2018 8695212/2/2018 87882, 11/11/2018 88612, 12/28/2018 88934, 11/28/2017 89105, 10/2/2018 89214, 11/19/2018 89473, 1/2/2019 89751, 1/21/2019 95234, 1/7/2019 96087, 1/9/2019 97240, 4/5/2018 97339, 5/13/2019 97525, 6/19/2019 97802, 6/10/2018 97958, 6/4/2019 98056, 6/29/2019 98591, 6/30/2019 99911, 9/24/2019 99918, 6/20/2019
- 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 of the custom Aligned Medical Solutions (AMS) kits 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:
Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor Pack, part number PSS3541(A
Product Codes/Lot Numbers:
Lot number and expiration date 100188, 10/19/2019 100884, 9/17/2019 84683, 5/27/2018 85122, 6/3/2018 85476, 8/17/2018 85717, 7/21/2018 86693, 9/3/2018 8695212/2/2018 87882, 11/11/2018 88612, 12/28/2018 88934, 11/28/2017 89105, 10/2/2018 89214, 11/19/2018 89473, 1/2/2019 89751, 1/21/2019 95234, 1/7/2019 96087, 1/9/2019 97240, 4/5/2018 97339, 5/13/2019 97525, 6/19/2019 97802, 6/10/2018 97958, 6/4/2019 98056, 6/29/2019 98591, 6/30/2019 99911, 9/24/2019 99918, 6/20/2019
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1341-2017
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The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Windstone Medical Packaging
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).