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Date Issued: November 30, 2023
RE: FDA Safety Communication: Syringes Made in China
MYCO Medical, Inc, (MYCO) is informing customers, health care providers, and distributors that the RELI® brand syringes and syringes with needles attached packaged under the RELI® brand have been quality tested by an independent 3rd party for accuracy and overall quality performance.
We support the FDA’s decision to increase awareness of recent quality issues of other manufacturers in China for reported for leaks, breakage, and other problems due to changes in some manufacturers’ syringe dimensions. Since MYCO launched our luer lock syringe in 2021, there have been no material or dimensional changes commissioned with our factory.
MYCO and our manufacturing partners conducted US based 3rd party testing by a leading test facility and found that all RELI® brand syringes met or exceeded the industry standards for dimension and functionality over a wide range of performance criteria.
MYCO has a long-standing commitment to patient safety and quality, and we stand behind our line of syringes and syringes with needles attached sourced from our China-based manufacturing partner. If you have been impacted by the quality issues reported by the recent FDA communication and are in need of alternative supply, MYCO is confidently ready to support any healthcare provider or distributor.
For questions about RELI® brand syringes, please contact customerservice@mycomedical.com or call 800-454-9626. For more details about our syringes or any of our products, see our website here www.mycomedical.com. To report an issue with a RELI® syringe, please contact QA@mymedical.com, or call 800-454-6929.
If you are experiencing supply shortages due to this FDA action, please contact our Sales team at Sales@mycomedical.com or call 800-454-6929 or 919-460-2535 ext. 201.
RELI® Syringe Catalog Reference Numbers:
Part Number, Description
S1ML-LDS, Reli® Syringe, 1ML, Low Dead Space, 100ea/bx, 36bx/cs
S3ML-LDS, Reli® Syringe, 3ML, Low Dead Space, 100ea/bx, 32bx/cs
S5ML, Reli® Syringe, 5ML, 100ea/bx, 24bx/cs
S10ML, Reli® Syringe, 10ML, 100ea/bx, 15bx/cs
S20ML, Reli® Syringe, 20ML, 50ea/bx, 12bx/cs
S30ML, Reli® Syringe, 30ML, 40ea/bx, 4bx/cs
S60ML, Reli® Syringe, 60ML, 30ea/bx, 10bx/cs
RELI® Syringe with Needle Catalog Reference Numbers:
Part Number, Description
HYP20G101-RW-S10ML, 10ML Syringe with Detachable Hypodermic Needle, 20G x 1", Regular Wall, Regular Bevel
HYP20G101-RW-S3ML, 3ML Syringe (Low Dead Space) with Detachable Hypodermic Needle, 20G x 1", Regular Wall, Regular Bevel
HYP20G101-RW-S5ML, 5ML Syringe with Detachable Hypodermic Needle, 20G x 1", Regular Wall, Regular Bevel
HYP20G151-RW-S3ML, 3ML Syringe (Low Dead Space) with Detachable Hypodermic Needle, 20G x 1.5", Regular Wall, Regular Bevel
HYP21G101-RW-S5ML, 5ML Syringe with Detachable Hypodermic Needle, 21G x 1", Regular Wall, Regular Bevel
HYP21G101-TW-S3ML, 3ML Syringe (Low Dead Space) with Detachable Hypodermic Needle, 21G x 1", Thin Wall, Regular Bevel
HYP21G151-RW-S3ML, 3ML Syringe (Low Dead Space) with Detachable Hypodermic Needle, 21G x 1.5", Regular Wall, Regular Bevel
HYP22G101-RW-S3ML, 3ML Syringe (Low Dead Space) with Detachable Hypodermic Needle, 22G x 1", Regular Wall, Regular Bevel
HYP22G151-RW-S3ML, 3ML Syringe (Low Dead Space) with Detachable Hypodermic Needle, 22G x 1.5", Regular Wall, Regular Bevel
HYP23G101-TW-S3ML, 3ML Syringe (Low Dead Space) with Detachable Hypodermic Needle, 23G x 1", Thin Wall, Regular Bevel
HYP25G6251-TW-S1ML, 1ML Syringe (Low Dead Space) with Detachable Hypodermic Needle, 25G x 0.625", Thin Wall, Regular Bevel
HYP25G6251-TW-S3ML, 3ML Syringe (Low Dead Space) with Detachable Hypodermic Needle, 25G x 0.625", Thin Wall, Regular Bevel
HYP27G051-RW-S1ML, 1ML Syringe (Low Dead Space) with Detachable Hypodermic Needle, 27G x 0.5", Regular Wall, Regular Bevel
SHN18G101-S1ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 1ml, 18G x 1", 100ea/bx, 12bx/cs
SHN18G101-S3ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 3ml, 18G x 1", 100ea/bx, 8bx/cs
SHN18G151-S3ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 3ml, 18G x 1.5", 100ea/bx, 8bx/cs
SHN19G101-S3ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 3ml, 19G x 1", 100ea/bx, 8bx/cs
SHN19G151-S3ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 3ml, 19G x 1.5", 100ea/bx, 8bx/cs
SHN20G101-S3ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 3ml, 20G x 1", 100ea/bx, 8bx/cs
SHN20G151-S3ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 3ml, 20G x 1.5", 100ea/bx, 8bx/cs
SHN21G101-S3ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 3ml, 21G x 1", 100ea/bx, 8bx/cs
SHN21G151-S3ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 3ml, 21G x 1.5", 100ea/bx, 8bx/cs
SHN22G151-S3ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 3ml, 22G x 1.5", 100ea/bx, 8bx/cs
SHN23G1251-S3ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 3ml, 23G x 1.25", 100ea/bx, 8bx/cs
SHN23G151-S3ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 3ml, 23G x 1.5", 100ea/bx, 8bx/cs
SHN24G101-S3ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 3ml, 24G x 1", 100ea/bx, 8bx/cs
SHN25G151-S3ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 3ml, 25G x 1.5", 100ea/bx, 8bx/cs
SHN25G6251-S1ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 1ml, 25G x 5/8", 100ea/bx, 12bx/cs
SHN25G6251-S3ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 3ml, 25G x 5/8", 100ea/bx, 8bx/cs
SHN27G051-S1ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 1ml, 27G x 1/2", 100ea/bx, 12bx/cs
SHN27G6251-S1ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 1ml, 27G x 5/8", 100ea/bx, 12bx/cs
SHN30G051-S1ML-LDS, Reli® Safety Hypodermic Needle with Syringe, Low Dead Space, 1ml, 30G x 1/2", 100ea/bx, 12bx/cs
SHN20G101-S10ML, Safety Hypodermic Needle with Syringe, 10ml, 20G x 1"
SHN20G101-S5ML, Safety Hypodermic Needle with Syringe, 5ml, 20G x 1"
SHN20G151-S10ML, Safety Hypodermic Needle with Syringe, 10ml, 20G x 1.5"
SHN20G151-S5ML, Safety Hypodermic Needle with Syringe, 5ml, 20G x 1.5"
SHN21G101-S10ML, Safety Hypodermic Needle with Syringe, 10ml, 21G x 1"
SHN21G101-S5ML, Safety Hypodermic Needle with Syringe, 5ml, 21G x 1"
SHN21G151-S10ML, Safety Hypodermic Needle with Syringe, 10ml, 21G x 1.5"
SHN21G151-S5ML, Safety Hypodermic Needle with Syringe, 5ml, 21G x 1.5"
SHN22G151-S10ML, Reli® Safety Hypodermic Needle with Syringe, 10ml, 22G x 1.5"
SHN22G151-S5ML, Reli® Safety Hypodermic Needle with Syringe, 5ml, 22G x 1.5"
S3ML-BFN18G151, Syringe, 3ml with 18G x 1.5" Reli® Blunt Fill Needle Attached
S5ML-BFN18G151, Syringe, 5ml with 18G x 1.5" Reli® Blunt Fill Needle Attached
S10ML-BFN18G151, Syringe, 10ml with 18G x 1.5" Reli® Blunt Fill Needle Attached
INSY27G051-S1ML, Safety Insulin Syringe, 1ml, 27G x 1/2"
INSY28G051-S.5ML, Safety Insulin Syringe, 0.5ml, 28G x 1/2"
INSY28G051-S1ML, Safety Insulin Syringe, 1ml, 28G x 1/2"
INSY28G101-S1ML, Safety Insulin Syringe, 1ml, 28G x 1"
INSY29G051-S.3ML, Safety Insulin Syringe, 0.3ml, 29G x 1/2"
INSY29G051-S.5ML, Safety Insulin Syringe, 0.5ml, 29G x 1/2"
INSY29G051-S1ML, Safety Insulin Syringe, 1ml, 29G x 1/2"
INSY30G051-S.3ML, Safety Insulin Syringe, 0.3ml, 30G x 1/2"
INSY30G051-S.5ML, Safety Insulin Syringe, 0.5ml, 30G x 1/2"
INSY30G18751-S.5ML, Safety Insulin Syringe, 0.5ml, 30G x 3/16"
INSY30G18751-S1ML, Safety Insulin Syringe, 1ml, 30G x 3/16"
INSY30G31251-S.3ML, Safety Insulin Syringe, 0.3ml, 30G x 5/16"
INSY30G31251-S.5ML, Safety Insulin Syringe, 0.5ml, 30G x 5/16"
INSY30G31251-S1ML, Safety Insulin Syringe, 1ml, 30G x 5/16"
INSY31G31251-S.3ML, Safety Insulin Syringe, 0.3ml, 31G x 5/16"
INSY31G31251-S.5ML, Safety Insulin Syringe, 0.5ml, 31G x 5/16"
INSY31G31251-S1ML, Safety Insulin Syringe, 1ml, 31G x 5/16"
