Hysteroscopy Pack, part number AMS4797 Hysteroscopy Pack, part number AMS4797(A Hysteroscopy Pack, part number AMS4797(B
Reported: March 8, 2017 Initiated: January 11, 2017 #Z-1319-2017
Product Description
Hysteroscopy Pack, part number AMS4797 Hysteroscopy Pack, part number AMS4797(A Hysteroscopy Pack, part number AMS4797(B
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.
Details
- Recalling Firm
- Windstone Medical Packaging, Inc.
- Units Affected
- 130 kits
- Distribution
- Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
- Location
- Billings, MT
Frequently Asked Questions
What product was recalled? ▼
Hysteroscopy Pack, part number AMS4797 Hysteroscopy Pack, part number AMS4797(A Hysteroscopy Pack, part number AMS4797(B. Recalled by Windstone Medical Packaging, Inc.. Units affected: 130 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 8, 2017. Severity: Moderate. Recall number: Z-1319-2017.
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