CLASS II Device recall · Reported 26 Oct 2016 · FDA Enforcement Report
Basic Tray, Kit part numbers AMS1199(A recalled
Windstone Medical Packaging is recalling Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for, distributed nationwide in the US. The recall was initiated on 22 Apr 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0149-2017
- FDA event ID
- 71968
- Recalling firm
- Windstone Medical Packaging, Billings, MT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Apr 2015
- FDA classified
- 20 Oct 2016
- Reported
- 26 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 22 Apr 2015 | Recall initiated by company | |
| 20 Oct 2016 | Classified by FDA | +547 days |
| 26 Oct 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room
Where it was distributed
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Nationwide CaliforniaFloridaGeorgiaIllinoisKansasLouisianaMichiganNew JerseyNevadaTexasVirginiaWyoming
Questions about this recall
Is Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for recalled?
Yes. Windstone Medical Packaging recalled Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for on 22 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-0149-2017.
Why was it recalled?
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.
Which lots are affected?
Lot Numbers/Expiration Dates: 56958 5/29/2016 56991 6/4/2016 57637 7/5/2016 57788 7/10/2016 59063 1/22/2016 59363 3/24/2015 60073 10/30/2016 60752 10/29/2015 61309 9/27/2015 62116 11/28/2015 62453 11/14/2015 62727 11/5/2015 63987 1/8/2016 64556 1/6/2016 65214 1/1/2016 65698 11/30/2015 66531 8/9/2016 66620 11/9/2015 68220 9/28/2016 68650 9/13/2016 69059 9/22/2016 69210 5/26/2016 69417 9/7/2016 69787 1/29/2017 70198 11/30/2016 70590 9/21/2016 70993 12/6/2016 71368 12/13/2016 71904 3/30/2017 72550 1/10/2017 72914 3/29/2017 73285 7/21/2017 73824 4/5/2017 74175 5/3/2017 75314 5/11/2017 75728 7/3/2017 76171 7/7/2017 76624 8/4/2017 77162 8/10/2017 77576 10/8/2017 77742 10/2/2017 78128 9/30/2017 78139 9/22/2017 79481 1/23/2018
Where was it sold?
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Windstone Medical Packaging
All 337| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Sterility | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
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