Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A,…
Medical device recall Z-0204-2017. 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
- 8132 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 Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surgery in hospital operating room
8132 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot codes/Expiration dates: 65013 3/1/2014 58261 3/20/2014 58964 3/27/2014 61857 4/10/2014 60968 4/20/2014 57095 4/25/2014 59002 5/2/2014 60388 5/5/2014 60299 6/30/2014 62798 8/21/2014 62654 10/25/2014 64447 12/5/2014 63072 12/9/2014 64328…
Every code shown here, 2,000 characters
Lot codes/Expiration dates: 65013 3/1/2014 58261 3/20/2014 58964 3/27/2014 61857 4/10/2014 60968 4/20/2014 57095 4/25/2014 59002 5/2/2014 60388 5/5/2014 60299 6/30/2014 62798 8/21/2014 62654 10/25/2014 64447 12/5/2014 63072 12/9/2014 64328 12/13/2014 64679 12/18/2014 63368 12/20/2014 63799 1/13/2015 66644 2/2/2015 66509 2/14/2015 65777 2/25/2015 65573 2/25/2015 65718 2/28/2015 65875 3/6/2015 65572 3/15/2015 59027 3/26/2015 58692 4/5/2015 68613 4/12/2015 67175 4/14/2015 57249 4/20/2015 68069 4/28/2015 59297 7/3/2015 59538 7/4/2015 59157 7/13/2015 59846 8/2/2015 60663 8/4/2015 60131 8/5/2015 60113 8/6/2015 60132 8/6/2015 70171 8/13/2015 61311 8/18/2015 61435 8/20/2015 59514 8/24/2015 59845 8/31/2015 60605 9/7/2015 60754 9/7/2015 61006 9/7/2015 60722 9/11/2015 61164 9/14/2015 60662 9/20/2015 61479 9/21/2015 68892 9/29/2015 61310 10/16/2015 65295 11/2/2015 71133 11/2/2015 62199 11/5/2015 62600 11/5/2015 62349 11/6/2015 61601 11/6/2015 64476 11/6/2015 66318 11/6/2015 61521 11/7/2015 66319 11/8/2015 65296 11/10/2015 64850 11/11/2015 64477 11/11/2015 62200 11/13/2015 62943 11/13/2015 70754 11/13/2015 62903 11/14/2015 63199 11/15/2015 61602 11/23/2015 61642 11/26/2015 62425 11/27/2015 62546 11/27/2015 66795 11/27/2015 61603 11/29/2015 65598 11/30/2015 65700 11/30/2015 72347 12/4/2015 72783 12/15/2015 72804 12/21/2015 65699 12/23/2015 65294 12/26/2015 65195 12/27/2015 64632 1/2/2016 73047 1/6/2016 64291 1/7/2016 64349 1/8/2016 63430 1/9/2016 65019 1/12/2016 64475 1/16/2016 63200 1/18/2016 63711 1/22/2016 63948 1/25/2016 64042 1/30/2016 63984 1/30/2016 67589 2/5/2016 69258 2/5/2016 69459 2/5/2016 71210 2/11/2016 66794 2/14/2016 68862 2/14/2016 69603 2/20/2016 69604 2/20/2016 67588 2/24/2016 74530 2/25/2016 73860 3/6/2016 74555 3/10/2016 68572 3/13/2016 68863 3/22/2016 69062 3/26/2016 66552 4/4/2016 70511 4/6/2016 71878 4/8/2016 70512 4/10/2016 70267 4/14/2016 70268 4/16/2016 74731 4/18/2016 69605 4/20/2016 69866 4/23/2016 70510 4/24/2016 73286 4/24/2016 74443 4/25/2016 77115…
FDA’s list runs to 2,723 characters. The first part is shown; the rest is on FDA’s record.
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.”
- FDA’s list of codes runs to 2,723 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.