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510(k) K063755 · MEG Syringe, Antistick

PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE

Applicant	Smiths Medical Asd, Inc., Keene NH, US
Decision	Substantially Equivalent, Feb 27, 2007
Received	Dec 19, 2006
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K063755

Date	Firm and product	Code	Linked 510(k)
Jun 10, 2021	Smiths Medical ASD Inc. JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1 Terminated	MEG	None listed
Jan 8, 2014	Smiths Medical ASD, Inc. Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogen Terminated	MEG	None listed
Jan 8, 2014	Smiths Medical ASD, Inc. Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogen Terminated	MEG	None listed
Jan 8, 2014	Smiths Medical ASD, Inc. Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogen Terminated	MEG	None listed
Jan 8, 2014	Smiths Medical ASD, Inc. Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED012905-IN Hypodermic Needle-Pro Fixed Terminated	MEG	None listed
Jan 8, 2014	Smiths Medical ASD, Inc. Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED052905IN Hypodermic Needle-Pro Fixe Terminated	MEG	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.