Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple
Medical device recall Z-1235-2020. Published in FDA’s Enforcement Report on Feb 26, 2020.
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 Feb 26, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2,161,526 units (113, 711 additional units as of 2/25/20) 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 kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
2,161,526 units (113, 711 additional units as of 2/25/20), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Catalog Number and Lot Code: CHIP99CP6C 241107; CHIP99CP6C 255309; CHIP99CP6C 299932; CHIP99CP8A 181346; CHIP99CP8A 282695; CHIP99CP8A 282696; CHIP99CP8A 282697; CHIP99HA1B 165018; CHIP99HA1B 248383; CHIP99HA1B 305740; CHIP99HA1B 330666;…
Every code shown here, 1,997 characters
Catalog Number and Lot Code: CHIP99CP6C 241107; CHIP99CP6C 255309; CHIP99CP6C 299932; CHIP99CP8A 181346; CHIP99CP8A 282695; CHIP99CP8A 282696; CHIP99CP8A 282697; CHIP99HA1B 165018; CHIP99HA1B 248383; CHIP99HA1B 305740; CHIP99HA1B 330666; CHIP99HA1B 330666; CHIP99HA1B 363766; CHIP99LC1F 118473; CHIP99LC1F 279185; CHIP99LC1F 298252; CHIP99LC1F 309240; CHIP99LC1F 340201; CHIP99LC1F 340315; CHIP99LC1F 367435; CHIP99LC2E 248115; CHIP99LC2E 306502; CHIP99LC2E 321583; CHIP99LC2E 358454; CHIP99LC3D 147129; CHIP99LC3D 294307; CHIP99LC3D 334112; CHIP99MJ1E 987331; CHIP99MJ1E 988306; CHIP99MJ1E 123963; CHIP99MJ1E 127110; CHIP99MJ1E 152812; CHIP99MJ1E 154622; CHIP99MJ1E 174616; CHIP99MJ1E 201151; CHIP99MJ1E 230122; CHIP99MJ1E 255908; CHIP99MJ1E 282115; CHIP99MJ1E 282116; CHIP99MJ1E 282116; CHIP99MJ1E 282117; CHIP99MJ1E 308190; CHIP99MJ1E 308190; CHIP99MJ1E 311734; CHIP99MJ1E 321582; CHIP99MJ1E 327149; CHIP99MJ1E 368850; CHIP99MJ27 986631; CHIP99MJ28 988301; CHIP99MJ2F 993366; CHIP99MJ2F 110964; CHIP99MJ2F 127712; CHIP99MJ2F 127788; CHIP99MJ2F 136904; CHIP99MJ2F 152794; CHIP99MJ2F 161457; CHIP99MJ2F 163530; CHIP99MJ2F 163531; CHIP99MJ2F 226246; CHIP99MJ2F 246453; CHIP99MJ2F 246874; CHIP99MJ2F 246874; CHIP99MJ2F 248000; CHIP99MJ2F 269005; CHIP99MJ2F 269708; CHIP99MJ2F 273783; CHIP99MJ2F 286140; CHIP99MJ2F 286141; CHIP99MJ2F 288802; CHIP99MJ2F 310771; CHIP99MJ2F 310771; CHIP99MJ2F 310772; CHIP99MJ2F 313647; CHIP99MJ2F 320890; CHIP99MJ2F 320890; CHIP99MJ2F 321328; CHIP99MJ2F 340923; CHIP99MJ2F 358248; CHIP99MJ2F 368846; CHIP99MN1E 147122; CHIP99MN1E 330667; CHIP99MN21 134960; CHIP99MN2F 993391; CHIP99MN2F 308116; CHIP99MN2F 358455; CHIP99MN3D 154828; CHIP99MN3D 310774; CHIP99MN3D 311660; CHIP99MN3D 311660; CHIP99MN3D 330333; CHIP99MN3D 337741; CHIP99MN3D 372603; CHIP99MN3D 372603; CHIP99NC4D 260610; CHIP99NC4D 308198; CHIP99PM3E 260617; CHIP99PM3E 325765; CHIP99PM3E 325765; CHIP99PM4C 279694; CHIP99PM4C 288373; CHIP99PM5A 176703; CHIP99PM5A 176703; CHIP99PM5A 205583; CHIP99PM5A…
FDA’s list runs to 697,933 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.
US Nationwide.
These words name no state.
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 Jan 31, 2020.
- FDA classified it on Feb 14, 2020.
- FDA’s Enforcement Report published it on Feb 26, 2020.
- FDA terminated it on Jan 19, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cardinal Health 200, LLC, of Waukegan, IL.
- 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 697,933 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.