DeRoyal recalls sterile custom kits with BD PosiFlush syringes due to packaging defects. Affected kits include specific model numbers and lot dates. Consumers should check their kits for the listed serial numbers and contact DeRoyal for details.
“DeRoyal Sterile Custom Kits Recall: Packaging Defect Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65294-deroyal-sterile-custom-kits-recall-packaging-defect-risk. Based on FDA recall #Z-1963-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1963-2020%22&limit=1).
The FDA announced on April 24, 2020, that DeRoyal Industries Inc is recalling DeRoyal Sterile Custom Kits packaged with BD PosiFlush SF Saline Flush Syringes due to holes in the packaging. The recall affects 352 trays containing 7,923 syringes distributed in Tennessee, Maryland, Minnesota, North Dakota, New York, Florida, Massachusetts, and Rhode Island.
How to tell if you have it
Brand: DeRoyal
Product: DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe
a. H* Vein Pack Pgybk, 89-6209.03
b. H* Vein Pack, 89-6209.04
c. PICC Line Tray Pgybk, 89-6150.12
d. Umbilical Arterial Cath, 89-9370.01
e. Port Pack Pgybk, 89-8748.03
f. Port Pack Pgybk, 89-8748.04
g. Central Line Pack Pgybk, 89-8448.02
h.CV Insertion Kit II Pgybk, 89-9417.03
I. CV Insertion Kit II Pgybk, 89-9417.04
j. Right Heart Introducer Pgybk, 89-8495.04
k. Vein Pack Pgybk, 89-10400.01
The hazard
DeRoyal manufactured procedure packs using BD PosiFlush syringes which were subsequently recalled due to holes in the packaging.
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 DeRoyal Myocardial Probe Recall (August 20, 2026), DeRoyal Covaderm Plus Dressing Recall (May 18, 2026), and DeRoyal Suction Tubing Recall (January 31, 2025).
How to tell if you have this one
Check for model numbers like '89-6209.03' or '89-8748.04' on the kit packaging. Look for lot numbers and expiration dates listed in the recall notice, such as '49935860 exp 4/1/2021' or '51458994 exp 2/1/2022'.
Brand
DeRoyal
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Packaging
Look for model numbers and lot numbers on the kit packaging to determine if it is affected by this recall.
Contact DeRoyal
Reach out to DeRoyal Industries Inc for specific instructions on how to return or replace the affected kits.
Where it went and when
Where it was distributed
Distributed in 8 states.
Listed by the agency
Not listed
FDA distribution: “US distribution in the states of TN, MD, MN, ND, NY, FL, MA, RI” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Maryland, Massachusetts, Minnesota, New York, North Dakota, Rhode Island, 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-1963-2020 (April 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1963-2020 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.