FDAFDA · Food and drugs·Recall number Z-1798-2017
Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
Published April 19, 2017 · Recall initiated: March 16, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Windstone Medical Packaging, Inc.
- Distributor
- Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
- Lot
- Lot numbers: 84197 85135 86063 87112 88181 89030 94937 95806 96599 97277 97705 99303 100020
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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