Various Angiography/Cath Lab packs/trays
Medical device recall Z-1690-2022. Published in FDA’s Enforcement Report on Sep 14, 2022.
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 Sep 14, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 13 states named in where it went
- 61 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?
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Various Angiography/Cath Lab packs/trays
61 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRCUSTCATHG,2104091, 911211, 44064504 2) LSRCARDCATHG,2105191, 874211, 14884701 3) LSRCARDCATHG,2106031, 861211, 14887382 4) LSRCFHCATHD,2106151, 839211, 14887387 5)…
Every code shown here, 1,994 characters
Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRCUSTCATHG,2104091, 911211, 44064504 2) LSRCARDCATHG,2105191, 874211, 14884701 3) LSRCARDCATHG,2106031, 861211, 14887382 4) LSRCFHCATHD,2106151, 839211, 14887387 5) LSRCARDCATHG,2106172, 842211, 14882944 6) LSRCARDCATHG,2106172, 842211, 14887386 7) LSRCUSTCATHG,2106181, 840211, 44251069 8) LSRCFHCATHD,2107102, 810211, 15020227 9) LSRCFHCATHD,2107102, 810211, 15020826 10) LSRCFHCATHD,2107262, 807211, 15020266 11) LSRSPECPROCF,2107262, 803211, 64117654 12) LSRCARDCATHG,2108171, 783211, 44139783 13) LSRCFHCATHD,2109071, 765211, 44376128 14) LSRCFHCATHD,2109071, 765211, 44376127 15) LSRCFHCATHD,2109071, 765211, 44376129 16) LSRCFHCATHD,2109071, 765211, 44376130 17) LSRCUSTCATHG,2109201, 754211, 44373704 18) LSRCFHCATHD,2109271, 740211, 15142078 19) MMCC14D,2104143, 898211, 64033893 20) IHCC03R,2107061, 819211, 44183402 21) HGCL69G,2107202, 803211, 15053840 22) UIRD89AE,2107293, 793211, 44181939 23) AMCL05M,2108131, 777211, 64230198 24) HGCL69G,2108313, 761211, 15062583 25) SHCA31I,2105142, 866211, 44111393-005 26) CXDP36N,2105241, 858211, 14854252-004 27) SHCA31I,2105261, 855211, 44131698-005 28) BLCL72K,2106141, 835211, 14994491-004 29) SACL75AK,2106212, 828211, 64071585-006 30) MECL20V,2107292, 805211, 44235192-005 31) SACL75AK,2107302, 789211, 64109974-006 32) SLBT02H,2108051, 784211, 44234510-005 33) AHCC27X,2109092, 748211, 64209383-006 34) BHCA49I,2107161, 817211, 44228705-005 35) BHCA49I,2107161, 817211, 44228708-005 36) SHCC17E,2107292, 793211, 44219151-005 37) SHIR38E,2108192, 721211, 14977781-004 38) BHCA49I,2108241, 768211, 44215236-005 39) BHCA49I,2108241, 768211, 44335430-005 40) BHCA49I,2108241, 768211, 44336206-005 41) TMCC25I,2108312, 764211, 63999207-006 42) TMCC25I,2108312, 764211, 63999208-006 43) TMCC25I,2108312, 764211, 63999206-006 44) TMCC25I,2108312, 764211, 63999205-006 45) TMCC25I,2108312, 764211, 63999204-006 46) SHDW24G,2109071, 754211, 44344585-005 47) SHDW24G,2109071,…
FDA’s list runs to 2,602 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.
Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
The states and territories these words name
13 states and territories.
Every one of them
- Arizona
- Florida
- Iowa
- Illinois
- Massachusetts
- Minnesota
- Missouri
- Nebraska
- Ohio
- Pennsylvania
- Rhode Island
- South Dakota
- Texas
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Jun 16, 2022.
- FDA classified it on Sep 8, 2022.
- FDA’s Enforcement Report published it on Sep 14, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- American Contract Systems, Inc., of Kansas City, MO.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
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 2,602 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
-
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.