Safety hypodermic needle \u2013 25G x 1\ with pivoting safety shield
Certifications
Class IIa medical device (hypodermic needle) marketed in the EU/UK with CE marking in accordance with applicable medical device legislation.
Designed and manufactured under ISO 13485 Certified quality management systems at manufacturer level (Sol Millennium Medical).
Conforms to the requirements of Directive 2010/32/EU regarding prevention of sharps injuries in the hospital and healthcare sector.
Class IIa medical device (hypodermic needle) marketed in the EU/UK with CE marking in accordance with applicable medical device legislation.
Designed and manufactured under ISO 13485 Certified quality management systems at manufacturer level (Sol Millennium Medical).
Conforms to the requirements of Directive 2010/32/EU regarding prevention of sharps injuries in the hospital and healthcare sector.
Colour coding and labelling in line with ISO 6009 for identification of needle gauge.
Safety hypodermic needle \u2013 25G x 1\ with pivoting safety shield
Description
The Sol-Care 25G x 1\ (25mm) Safety Needle is a sterile, single-use hypodermic needle with an integrated pivoting safety shield designed to help prevent needlestick injuries during medication administration and general injection procedures. Each orange-coded 25-gauge, 1-inch needle is equipped with a hinged protective arm that can be activated using a simple one-handed technique, either by thumb activation or by pressing against a hard surface. When correctly engaged, the patented locking mechanism produces an audible click and fully encloses the needle point, reducing the risk of accidental needlestick injury while maintaining clear visibility of the injection site. The bevel-up, regular-wall stainless steel needle allows low-angle injections and is compatible with standard Luer syringes.
Bnefits
Integrated pivoting safety shield with one-hand activation helps reduce the risk of needlestick injuries after injection.
Audible click upon activation confirms that the safety mechanism is fully engaged and locked over the needle.
Patented locking mechanism ensures the needle is securely and completely locked in the protective arm, preventing re-exposure of the needle point under normal handling.
Two activation options – thumb activation or hard surface activation – support flexible, ergonomic use in different clinical situations.
Protective arm is designed not to obstruct visibility of the injection site, aiding accurate needle placement.
Bevel-up orientation and regular-wall needle construction allow low-angle injections and smooth tissue penetration.
Color-coded orange hub and shield for easy gauge identification in line with ISO 6009 colour coding.
Designed to comply with the requirements of Directive 2010/32/EU on the prevention of sharps injuries in the hospital and healthcare sector.
Compatible with standard Luer syringes for general-purpose injection and aspiration of fluids from vials, ampoules and subcutaneous or intramuscular sites.
Indications
General purpose hypodermic injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.
Medication administration via subcutaneous or intramuscular injection using standard Luer syringes.
Colour coding and labelling in line with ISO 6009 for identification of needle gauge.
Situations where a safety-engineered needle is required or recommended to reduce risk of sharps and needlestick injuries, in line with Directive 2010/32/EU and local policies.
Safety mechanism: hinged / pivoting protective arm manufactured from medical-grade polymer, mechanically linked to the hub and designed to fully cover the needle after use.
Hub: standard Luer hub in orange-coloured medical-grade plastic, colour-coded according to ISO 6009 for a 25-gauge needle.
Sterilisation: sterile, single-use device (typically sterilised by ethylene oxide, as specified in technical data sheets).
Packaging materials: blister or unit packaging and chipboard/carton outer box suitable for medical device storage.
Formulation
Single-use sterile safety hypodermic needle only (no syringe included), with integrated pivoting shield.
Gauge and length: 25G x 1" (25 mm).
Standard Luer connection hub compatible with Luer and Luer-lock syringes.
Supplied non-pyrogenic and sterile for single patient use.
Packaging
100 safety needles per box (100/box).
Needles are individually packaged in sterile blister or peel-open packs for single use.
Outer carton labelled with product name, gauge, length, colour code (orange), SKU (SN2510), lot number, expiry date, sterility method and manufacturer information.
Usage
Verify the integrity of the individual sterile package and check the expiry date before use; do not use if the package is damaged or expired.
Attach the Sol-Care safety needle firmly onto a compatible Luer syringe using aseptic technique.
Perform the injection according to local clinical protocols, keeping the safety arm away from the injection field until the procedure is completed.
After completing the injection and before withdrawing from the patient, or immediately after withdrawal depending on local policy, activate the safety mechanism using one of the two approved methods: thumb activation (pressing the protective arm forward with the thumb until it covers the needle and clicks) or hard surface activation (pressing the protective arm against a firm surface until it fully covers the needle and an audible click is heard).
Confirm visually that the protective arm has completely covered the needle and that the mechanism is locked; do not attempt to defeat or re-open the shield once activated.
Dispose of the entire needle–syringe assembly directly into an approved sharps container immediately after use, in accordance with local sharps disposal and infection control policies.
Do not reuse or re-sterilise; the Sol-Care safety needle is intended for single use only.
Follow institutional guidelines and training for the correct use of safety-engineered devices to ensure maximum protection from needlestick injuries.
Contraindications
Do not use if the sterile packaging is damaged, opened or past the expiry date.
Not suitable for applications requiring specialised needle designs (e.g., dental, spinal, epidural or blood collection devices) unless specifically indicated by the manufacturer.
Use with caution in patients with known hypersensitivity to stainless steel or other materials of construction; alternative devices should be considered if a material allergy is suspected.
Do not use if the safety mechanism appears damaged, deformed or fails to function during pre-use inspection.
Adverse Effects
Typical injection-related effects such as transient pain or discomfort at the injection site, minor bleeding, bruising or local irritation.
Potential for infection at the injection site if aseptic technique is not followed.
As with all hypodermic needles, incorrect technique may lead to tissue trauma, nerve injury or intravascular injection when not intended.
Needlestick injuries may still occur if the safety mechanism is not activated correctly, is activated too late, or sharps handling procedures are not followed.
Storage Conditions
Store in a clean, dry environment at room temperature, away from direct sunlight and excessive heat or moisture.
Keep in original packaging until immediately prior to use to maintain sterility and product identification.
Avoid crushing or bending of boxes that could damage individual needle packs.
Observe any additional storage conditions or temperature limits indicated on the packaging.
