CLASS II Device recall · Reported 26 Oct 2016 · FDA Enforcement Report
Shoulder Arthroscopy Pack, Kit number 002648 recalled
Windstone Medical Packaging is recalling Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, 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-0269-2017
- 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
- Surgical Instruments
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
Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. 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 Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609 recalled?
Yes. Windstone Medical Packaging recalled Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609 on 22 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-0269-2017.
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 Number/ Expiration Date: 59007 8/27/2013 57610 8/31/2013 60128 12/15/2013 62099 12/21/2013 61297 2/9/2014 62189 2/12/2014 57522 4/30/2014 60028 5/12/2014 60303 5/19/2014 61416 8/17/2014 63836 9/7/2014 66799 9/19/2014 61924 12/3/2014 63333 12/8/2014 65167 12/31/2014 67369 2/4/2015 68073 4/17/2015 70983 9/6/2015 70169 9/21/2015 71061 10/10/2015 65331 11/5/2015 62082 11/7/2015 66580 11/20/2015 64544 1/29/2016 68947 2/19/2016 74854 3/23/2016 75534 4/25/2016 69610 5/7/2016 71352 6/17/2016 66677 7/5/2016 67866 7/6/2016 67702 7/30/2016 77629 7/30/2016 78550 7/30/2016 68712 9/13/2016 68215 9/17/2016 79701 10/11/2016 70494 10/17/2016 75648 12/1/2016 71381 12/12/2016 76128 1/22/2017 72479 3/15/2017 72951 3/24/2017 73131 4/15/2017 74758 5/5/2017 73849 5/7/2017 73192 5/30/2017 76672 7/17/2017 80956 8/8/2017 78024 8/23/2017 77684 10/24/2017 79660 1/9/2018 78944 1/16/2018
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 336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Sterility | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |