FDA-Device2021-06-16Class I
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
Smiths Medical ASD Inc.
Hazard
Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward.
Sold states
Worldwide distribution - US Nationwide and the countries of UK, Spain.
Affected count
1,432,200 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1798-2021Don't want to check this manually?
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