Lower riskMedical device recall · FDA · Published November 21, 2018
American Contract Systems recalls surgical kits with potential sterilization failure
American Contract Systems recalls Bag size #4 Custom Convenience Kits used in surgery that may not have reached complete sterilization. Affected kits include specific tray names and lot numbers.
“American Contract Systems recalls surgical kits with potential sterilization failure.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69441-american-contract-systems-recalls-surgical-kits-with-potential-sterilization-failure. Based on FDA recall #Z-0964-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0964-2019%22&limit=1).
The FDA announced on 2018-11-21 that American Contract Systems Inc voluntarily recalled Bag size #4 Custom Convenience Kits due to a potential for incomplete sterilization, according to GovInfoNow's records.
How to tell if you have it
Brand: American Contract Systems
Product: Bag size #4 Custom Convenience Kits (Surgical convenience kits)
Lot Codes: Various codes listed for each Tray Number (e.g., LSRBASICPACD lots include 1610281, 1611301, etc.)
Quantity: 51,152 units total
Distribution: Florida
The hazard
The hazard is the potential that the product has not reached complete sterilization, according to the FDA.
Context
GovInfoNow's records show American Contract Systems Inc has 21 other recalls on record since 2022-03-22. Other recent recalls of similar products include Medical Convenience Kits with Contaminated Wipes Risk Infection (2026-08-10), American Contract Systems Convenience Kits Recall: Catheters May Not Meet Performance Standards (2026-06-29), and American Contract Systems Medical Kits Recall: Potential Endotoxin Variability (2026-05-19). Other recent recalls of similar products include Medline Convenience Kits Recall: Sterility Risk from Calibration Issues (2026-01-07), Medline Convenience Kits Recall: Calibration Issues May Affect Sterility (2026-01-07), and Medline Convenience Kits: Risk of Contaminated Sterilized Products (2026-01-07).
How to tell if you have this one
Check for tray names like 'PACK BASIC' or similar surgical kit names. Look for specific tray numbers and lot numbers listed in the recall notice.
Brand
American Contract Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Identify the tray name and number on the kit to see if it matches the recalled items listed in the notice.
Where it went and when
Where it was distributed
Distributed in Florida.
Listed by the agency
Not listed
FDA distribution: “US Distribution is to Florida.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0964-2019 (November 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0964-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.