Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple
Medical device recall Z-1301-2020. 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
- 318,000 units 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
318,000 units, 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: PB08GAGHS 521235; PB08GAGHS 529320; PB08GAGHS 554815; PB08GAGHS 557236; PB08GAGHS 560162; PB08GAGHS 562676; PB08GIGHR 552864; PB08GIGHR 559707; PB08GIGHR 561420; PB08HSGH5 517846; PB08HSGHK 504968; PB08HSGHK…
Every code shown here, 1,991 characters
Catalog Number and Lot Code: PB08GAGHS 521235; PB08GAGHS 529320; PB08GAGHS 554815; PB08GAGHS 557236; PB08GAGHS 560162; PB08GAGHS 562676; PB08GIGHR 552864; PB08GIGHR 559707; PB08GIGHR 561420; PB08HSGH5 517846; PB08HSGHK 504968; PB08HSGHK 544674; PB08HSGHK 554810; PB08HSGHK 558443; PB08HSGHK 562679; PB08IVGH3 519354; PB08IVGHO 503340; PB08IVGHO 509979; PB08IVGHO 551950; PB08IVGHO 554195; PB08IVGHO 556756; PB08IVGHO 559958; PB08IVGHO 562283; PB08LSGH3 517883; PB08LSGHE 513408; PB08LSGHE 550220; PB08LSGHE 556248; PB08LSGHE 561562; PB08MVGHQ 521902; PB08MVGHQ 523275; PB08MVGHQ 528216; PB08MVGHQ 549498; PB08MVGHQ 556443; PB08MVGHQ 559599; PB08MVGHQ 562466; PB11DCXXA 344716; PB11DCXXA 372505; PB11FSCHN 541668; PB13LSFHG 195957; PB13LSFHG 316506; PB13LSFHG 350830; PB13LSFHH 373873; PB13UGNT7 303901; PB13UGNTJ 118704; PB13UGNTJ 143922; PB13UGNTK 255172; PB13UGNTK 327799; PB13UGNTK 360114; PB15LHFCJ 248323; PB15LHFCJ 312264; PB15LHFCJ 342369; PB15LHFCJ 366746; PB1DAHUNI 180662; PB1DAHUNJ 333601; PB1DAHUNJ 370040; PB1DDCSJI 108730; PB1DDCSJI 307803; PB1DDCSJI 346004; PB1DDCSJI 370354; PB1DLSUNK 285865; PB1DLSUNL 316031; PB1DLSUNL 333143; PB1DLSUNL 363057; PB23CSRDA 548637; PB23CSRDA 327807; PB23CSRDA 364216; PB23LSAHA 306987; PB23LSAHA 322477; PB23LSAHA 335255; PB23LSAHA 357206; PB23LSAHA 367905; PB23LSJMC 542909; PB23LTTUP 522394; PB23OTAHA 541850; PB23OTAHA 547585; PB23OTAHA 367276; PB23OTRCB 542969; PB29HDCC3 134009; PB29HDCCR 183332; PB29HDCCR 261607; PB29HDCCR 285835; PB29HDCCR 307192; PB29HDCCR 322158; PB29HDCCR 348523; PB29LSAGD 989849; PB29LSAGD 178065; PB29LSAGE 237501; PB29LSAGF 353393; PB29LSMHS 303470; PB29LSMHS 370550; PB29LSRMX 988029; PB29LSRMX 104626; PB29LSRMX 142666; PB29LSRMX 177005; PB29LSRMY 248367; PB29LSRMY 285431; PB29LSRMY 328739; PB29LSRMY 333744; PB29LSRMY 362336; PB29LVCC4 125637; PB29LVCCU 152306; PB29LVCCU 201568; PB29LVCCU 257269; PB29LVCCU 279756; PB29LVCCU 298260; PB29LVCCU 328486; PB29LVCCU 352634; PB29MNAGD 178045; PB29MNAGF 289378;…
FDA’s list runs to 111,251 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. Chile, Israel, UAE.
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 19, 2020.
- FDA’s Enforcement Report published it on Feb 26, 2020.
- FDA terminated it on Feb 1, 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 111,251 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.