Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported)

December 1, 2023

Retractable Technologies, Inc.

(Exact name of registrant as specified in its charter)

Texas	001-16465	75-2599762
(State or other jurisdiction	(Commission	(IRS Employer
of incorporation)	File Number)	Identification No.)

511 Lobo Lane, Little Elm, Texas	75068-5295
(Address of principal executive offices)	(Zip Code)

Registrant's telephone number, including area code

(972) 294-1010

None

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock	RVP	NYSE American

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01

Other Events.

On December 1, 2023, the Company issued a press release, a copy of which is attached to this Form 8-K as Exhibit 99, reporting that the FDA Safety Communication “Evaluating Plastic Syringes Made in China for Potential Device Failures” issued on November 30, 2023 does not refer to syringes from Retractable Technologies Inc.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

99	Press release

104	Cover Page Interactive Date File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

DATE: December 4, 2023	RETRACTABLE TECHNOLOGIES, INC.
	(Registrant)

	BY:	/s/ JOHN W. FORT III
		JOHN W. FORT III
		VICE PRESIDENT, CHIEF FINANCIAL OFFICER, AND CHIEF ACCOUNTING OFFICER

Exhibit 99

Retractable Technologies, Inc. Not Impacted by FDA Safety Communication

LITTLE ELM, TEXAS, December 1, 2023 — Retractable Technologies, Inc. (NYSE American: RVP) reports that the FDA Safety Communication “Evaluating Plastic Syringes Made in China for Potential Device Failures” on November 30, 2023 does not refer to syringes from Retractable Technologies Inc. The FDA identified quality issues related to “leaks, breakage, and other problems after manufacturers made changes to the syringe dimensions.” Retractable Technologies has not incorporated any recent changes to the dimensions of the syringe barrel on its gold-standard VanishPoint Safety Syringe. VanishPoint users can continue to be confident not only in VanishPoint’s ability to deliver the correct dose of medication, but also in its ability to protect users from needlesticks better than any other safety syringe.

If you have any questions or concerns about the FDA Safety Communication, please do not hesitate to contact us.

ABOUT RETRACTABLE

Retractable manufactures and markets VanishPoint^® and Patient Safe^® safety medical products and the EasyPoint^® needle. The VanishPoint^® syringe, blood collection, and IV catheter products are designed to prevent needlestick injuries and product reuse by retracting the needle directly from the patient, effectively reducing exposure to the contaminated needle. Patient Safe^® syringes are uniquely designed to reduce the risk of bloodstream infections resulting from catheter hub contamination. The EasyPoint^® is a retractable needle that can be used with luer lock syringes, luer slip syringes, and prefilled syringes to give injections. The EasyPoint^® needle also can be used to aspirate fluids and for blood collection. Retractable's products are distributed by various specialty and general line distributors.

For more information on Retractable, visit its website at www.retractable.com.

Forward-looking statements in this press release are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995 and reflect Retractable's current views with respect to future events. Retractable believes that the expectations reflected in such forward-looking statements are accurate. However, Retractable cannot assure you that such expectations will materialize. Actual future performance could differ materially from such statements.

Factors that could cause or contribute to such differences include, but are not limited to: material changes in demand, potential tariffs, Retractable's ability to maintain liquidity; Retractable's maintenance of patent protection; Retractable's ability to maintain favorable third party manufacturing and supplier arrangements and relationships; foreign trade risk; Retractable's ability to access the market; production costs; the impact of larger market players in providing devices to the safety market; and other risks and uncertainties that are detailed from time to time in Retractable's periodic reports filed with the U.S. Securities and Exchange Commission.

Retractable Technologies, Inc.

John W. Fort III, 888-806-2626 or 972-294-1010

Vice President, Chief Financial Officer, and Chief Accounting Officer

Cover	Dec. 01, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Dec. 01, 2023
Entity File Number	001-16465
Entity Registrant Name	Retractable Technologies, Inc.
Entity Central Index Key	0000946563
Entity Tax Identification Number	75-2599762
Entity Incorporation, State or Country Code	TX
Entity Address, Address Line One	511 Lobo Lane
Entity Address, City or Town	Little Elm
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	75068-5295
City Area Code	972
Local Phone Number	294-1010
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	RVP
Security Exchange Name	NYSEAMER
Entity Emerging Growth Company	false