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Date Issued: March 22, 2024
RE: FDA Update on ongoing evaluation of quality and performance issues related to plastic syringes made in China:
Earlier this week, the FDA’s Center for Devices and Radiological Health (CDRH) issued several warning letters to firms engaged in the manufacture and distribution of syringes into the US Market. Several of these firms are located in the US and have manufacturing relationships with companies that manufacture syringes in China. Neither MYCO® Medical, nor the RELI® brand nor our manufacturing partner were included in this action. We support the FDA’s recent actions to uphold their mission to protect and promote the public health. MYCO has a long-standing commitment to patient safety and quality, and we stand behind our line of syringes and syringes with needles attached that are sourced from our China-based manufacturing partner.
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 a US based independent 3rd party for accuracy and overall quality performance.
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 800-454-6926. For more details about our syringes or any of our products, see our web site here www.mycomedical.com. To report an issue with a RELI® syringe, please contact QA@mycomedical.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 800-454-6926 or 919-460-2535 ext. 201.
Tim Krotchko
Director of Quality & Regulatory Affairs
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"
