SUTURE REMOVAL TRAY, SET or KIT
Medical device recall Z-1079-2018. Published in FDA’s Enforcement Report on Mar 28, 2018.
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 28, 2018. Copied from openFDA on Oct 20, 2026.
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?
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SUTURE REMOVAL TRAY, SET or KIT
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
55160 55395 55525 60125 60255 60360 60365 75435 84105 86125 SR530 Lot codes: 2016011801 2016011290 2016022390 2016042990 2016061390 2016080390 2016101790 2017011090 2015111990 2017022790 2015062201 2015081001 2016032101 2016050901…
Every code shown here, 1,264 characters
55160 55395 55525 60125 60255 60360 60365 75435 84105 86125 SR530 Lot codes: 2016011801 2016011290 2016022390 2016042990 2016061390 2016080390 2016101790 2017011090 2015111990 2017022790 2015062201 2015081001 2016032101 2016050901 2016091201 2017032001 2017061501 2015042701 2015100501 2015120701 2016011101 2016071101 2016103101 2017011601 2017071201 2015100501 2016012501 2016071101 2016090501 2017013101 2017021601 2017051101 2017080701 2016060601 2017071101 2015111601 2016030701 2016101001 2015062201 2015110201 2016022201 2016091201 2015050401 2015082401 2016010401 2016072501 2017042401 2016101001 2017021301 2017071101 2016050201 2016111401 2015062901 2015081701 2015090701 2015110201 2016021501 2016040401 2016071101 2016102401 2016121401 2017021301 2017041901 2017070501 2017071801 2015072001 2016111401 2016021501 2016062001 2016081501 2016062701 2016040790 2015102990 2015120790 2016011890 2016050990 2016072590 2016091990 2017010390 2017012390 2017052290 2017062290 2015061501 2015081001 2015102601 2015122801 2016030701 2016050901 2016072501 2016101001 2016122701 2017041201 2017071001 2015060801 2015072001 2015082401 2015102601 2015122801 2016022201 2016050201 2016072501 2016091201 2016110701 2017022801 2017053101 2017060501 2016122001 2017041101
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.
Nationally
These words name no state.
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 Oct 23, 2017.
- FDA classified it on Mar 17, 2018.
- FDA’s Enforcement Report published it on Mar 28, 2018.
- FDA terminated it on Jun 21, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Centurion Medical Products Corporation, of Williamston, MI.
- 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.”
- 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.