Upper Extremity Pack
Medical device recall Z-1378-2017. Published in FDA’s Enforcement Report on Mar 8, 2017.
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 Mar 8, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 26 states named in where it went
- 1787 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 of the custom Aligned Medical Solutions (AMS) kits 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?
Upper Extremity Pack, part number AMS4670 Upper Extremity Pack, part number AMS4670(A
1787 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot number and expiration date 100052, 9/16/2018 84369, 6/20/2017 84721, 6/26/2017 84951, 6/21/2017 85377, 7/26/2017 86594, 10/8/2017 86595, 10/11/2017 87312, 10/24/2017 87990, 10/6/2017 88277, 10/26/2017 88668, 11/1/2017 89203, 12/16/2017…
Every code shown here, 526 characters
Lot number and expiration date 100052, 9/16/2018 84369, 6/20/2017 84721, 6/26/2017 84951, 6/21/2017 85377, 7/26/2017 86594, 10/8/2017 86595, 10/11/2017 87312, 10/24/2017 87990, 10/6/2017 88277, 10/26/2017 88668, 11/1/2017 89203, 12/16/2017 89605, 12/17/2017 94907, 12/28/2017 94968, 12/5/2017 95303, 2/27/2018 95476, 2/20/2018 96326, 2/1/2018 96619, 2/10/2018 96788, 2/1/2018 96950, 1/5/2018 97302, 3/20/2018 97596, 4/28/2018 97819, 3/15/2018 98048, 3/24/2018 98529, 5/30/2018 98710, 6/10/2018 98945, 5/24/2018 98946, 6/7/2018
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.
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.
The states and territories these words name
26 states and territories.
Every one of them
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Illinois
- Indiana
- Kansas
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- Nevada
- Ohio
- Pennsylvania
- Texas
- Utah
- Virginia
- Washington
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Jan 11, 2017.
- FDA classified it on Feb 28, 2017.
- FDA’s Enforcement Report published it on Mar 8, 2017.
- FDA terminated it on May 3, 2017.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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
-
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.