Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D PSS2365(E, convenience custom kits used for general…
Medical device recall Z-0205-2017. Published in FDA’s Enforcement Report on Oct 26, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 26, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 12 states named
- 3444 kits how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D PSS2365(E, convenience custom kits used for general surgery in hospital operating room
3444 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot numbers/Expiration dates: 62742 2/28/2014 65112 3/23/2014 65816 4/24/2014 56706 5/15/2014 66648 7/21/2014 66649 7/21/2014 66165 7/25/2014 57524 9/1/2014 57338 9/20/2014 57977 9/22/2014 56883 9/24/2014 57057 9/24/2014 57523 9/25/2014…
Every code shown here, 1,037 characters
Lot numbers/Expiration dates: 62742 2/28/2014 65112 3/23/2014 65816 4/24/2014 56706 5/15/2014 66648 7/21/2014 66649 7/21/2014 66165 7/25/2014 57524 9/1/2014 57338 9/20/2014 57977 9/22/2014 56883 9/24/2014 57057 9/24/2014 57523 9/25/2014 58348 1/3/2015 58349 1/4/2015 59680 1/17/2015 60694 1/24/2015 59678 1/25/2015 59679 1/26/2015 59221 1/28/2015 60104 1/29/2015 61738 4/24/2015 61740 6/11/2015 64688 6/19/2015 63590 6/22/2015 63772 6/22/2015 64002 6/22/2015 61739 6/27/2015 63257 6/28/2015 67941 2/11/2016 69813 3/23/2016 69812 3/26/2016 70306 3/30/2016 70581 3/30/2016 68432 6/1/2016 68433 6/9/2016 68006 6/12/2016 68578 6/13/2016 68008 6/30/2016 68894 6/30/2016 75064 7/30/2016 75200 7/30/2016 75500 7/30/2016 75803 7/30/2016 71902 9/10/2016 70989 9/21/2016 72308 9/24/2016 72754 9/24/2016 71238 9/25/2016 74820 11/9/2016 73337 11/15/2016 73397 11/15/2016 74294 11/24/2016 72983 11/25/2016 73566 11/28/2016 78172 4/16/2017 78171 4/19/2017 77607 4/23/2017 76467 4/24/2017 77068 4/24/2017 78380 4/24/2017 80630 4/24/2017 79474 4/25/2017
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
The states and territories these words name
- California
- Florida
- Georgia
- Illinois
- Kansas
- Louisiana
- Michigan
- New Jersey
- Nevada
- Texas
- Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 22, 2015.
- FDA classified it on Oct 20, 2016.
- FDA’s Enforcement Report published it on Oct 26, 2016.
- FDA terminated it on Oct 25, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Windstone Medical Packaging, Inc., of Billings, MT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.