Setup Pack recall
Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
Why was Setup Pack recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current 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?
Lot numbers: 84197 85135 86063 87112 88181 89030 94937 95806 96599 97277 97705 99303 100020
- Product
- Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 500 kits
- Distribution
- Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
- Recall date
- April 19, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)