Use caution Medical device recall · FDA · Published December 14, 2020

Prytime Medical Reboa Catheter Kit Recall: Wrong Needle Risk

Prytime Medical recalls Reboa Catheter Introducer Kit (KT1835C) due to possible 21G needle instead of 18G. Using this wrong needle may cause procedure delays or injury during vascular access.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0959-2021Medical device Prytime Medical ›

Use caution until it’s fixed

There is a potential that a catheter convenience set contains a 21G access needle instead of the correct 18G needle. If the 21G needle is used to gain vascular access then the guidewire included in the kit will not pass through the access needle to facilitate insertion of an introducer sheath and could therefore cause procedure delay or injury.

Take action

Contact the company

Recalling firmPrytime Medical Devices, Inc.229 N Main St · Boerne, TX 78006-2035

✎ GovInfoNow plain-language explainer

Prytime Medical is recalling their Reboa Catheter Introducer Kit (KT1835C) because it might contain a 21G needle instead of the required 18G needle. This could lead to procedure delays or injury if the wrong needle is used during vascular access. Read more at govinfonow.com/recall/63666-prytime-medical-reboa-catheter-kit-recall-wrong-needle-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63666-prytime-medical-reboa-catheter-kit-recall-wrong-needle-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0959-2021

Cite this page

“Prytime Medical Reboa Catheter Kit Recall: Wrong Needle Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63666-prytime-medical-reboa-catheter-kit-recall-wrong-needle-risk. Based on FDA recall #Z-0959-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0959-2021%22&limit=1).

The FDA announced on Dec. 14, 2020, that Prytime Medical Devices, Inc. voluntarily recalled the PRYTIME MEDICAL REBOA Catheter Introducer Kit due to a potential needle size error. The hazard involves a catheter convenience set containing an incorrect 21G access needle instead of the specified 18G needle.

How to tell if you have it

Brand: Prytime Medical
Product: PRYTIME MEDICAL REBOA Catheter Introducer Kit
REF: KT1835C
Lot #: MFG 3590

The hazard

According to the FDA, there is a potential that a catheter convenience set contains a 21G access needle instead of the correct 18G needle. If the 21G needle is used to gain vascular access then the guidewire included in the kit will not pass through the access needle to facilitate insertion of an introducer sheath and could therefore cause procedure delay or injury.

Context

GovInfoNow's records show Prytime Medical Devices, Inc. has one other recall on record since Oct. 29, 2020: the PRYTIME MEDICAL ER-Reboa Plus Catheter Recall for incorrect balloon marking risk. Other recent recalls of similar products include DeRoyal Myocardial Probe Recall (Aug. 20, 2026), Medline Intubation Tray Recall (Dec. 24, 2025), and Medline Medical Procedure Kits Recall (May 4, 2026).

How to tell if you have this one

Check for the kit's reference number KT1835C. The kit contains a needle labeled 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA. It was sold with a UDI code (01) 0 0863092 00010 1 and lot number MFG 3590.

Brand
Prytime Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Contents
Verify the needle size is 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA as listed in the kit description.
Contact Manufacturer
Reach out to Prytime Medical for assistance with the recall if you have the kit.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 25 states.

FDA distribution: “US Nationwide distribution including in the states of NJ, NY, CA, TX, MI, MO, CO, MI, VA, DE, TN, MO, MT, AZ, FL, WI, SC, WA, TX, CT, IN, PA, ME, WI, MA, GA, OH, AR, UT, NY OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Indiana, Maine, Massachusetts, Michigan, Missouri, Montana, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

Dec 14, 2020Firm started the recall
Feb 5, 2021FDA classified it Class II
Feb 17, 2021Published in FDA’s Enforcement Report
Sep 28, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63666-prytime-medical-reboa-catheter-kit-recall-wrong-needle-risk">Prytime Medical Reboa Catheter Kit Recall: Wrong Needle Risk (GovInfoNow)</a>

Where this comes from

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-0959-2021 (December 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0959-2021 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.