Lower riskMedical device recall · FDA · Published August 12, 2022
DeRoyal Sterile Custom Kits Recall: Risk of Contaminated Medical Connectors
DeRoyal recalls sterile custom kits with ICU Medical MicroClave Clear Connectors due to potential contamination. Affected kits include specific lots and expiration dates; contact DeRoyal for details.
“DeRoyal Sterile Custom Kits Recall: Risk of Contaminated Medical Connectors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60169-deroyal-sterile-custom-kits-recall-risk-of-contaminated-medical-connectors. Based on FDA recall #Z-1668-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1668-2022%22&limit=1).
The FDA announced on August 12, 2022, that DeRoyal Industries Inc. is recalling DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors because the procedure packs contained a recalled product. The recall affects 1,306 kits distributed nationwide in Ohio and Tennessee.
Model/Item: NON-STERILE IR ADMISSION KIT / 89-8762.05
Lot: 57104020 (exp 07/01/2023)
UDI-DI (GTIN): 00749756883627
The hazard
The procedure packs contained a recalled product, according to the FDA. The agency classified the recall as Class II.
Context
GovInfoNow's records show DeRoyal Industries Inc. has 29 other recalls on record since June 7, 2017. Other recent recalls of similar products include the DeRoyal Myocardial Probe Recall (August 20, 2026), the DeRoyal Covaderm Plus Dressing Recall (May 18, 2026), and the DeRoyal Suction Tubing Recall (January 31, 2025). Other recent recalls of similar products include Medline Convenience Kits recalls dated July 10, 2026, and January 7, 2026.
How to tell if you have this one
Check for kits labeled 'NS CVR PREP PACK /89-6817.09' or 'NON-STERILE IR ADMISSION KIT / 89-8762.05' with specific lot numbers and expiration dates listed in the recall notice.
Brand
DeRoyal
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Labels
Look for the product codes and lot numbers listed in the recall notice to determine if your kit is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of OH and TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Ohio, Tennessee.
Recall timeline
FDA terminated this recall 2.1 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-1668-2022 (August 12, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1668-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.