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Recall Observatory FDA recall evidence

Device product

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

Z-1798-2021

May 17, 2021

Class I

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 87945
Status
Terminated
Classification
Class I
Quantity
1,432,200 units
Official record key
device-enforcement:Z-1798-2021

Official wording

Reason: 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.

Code information: a) REF 4428-1, Lot Numbers: 4046543 and 4062235 b) REF 4429-1, Lot Numbers: 4031846, 4031845, 4040734, 4043536, 4046545, 4046546, 4062239, 4062240, 4062238, 4062242, 4014096

Distribution pattern: Worldwide distribution - US Nationwide and the countries of UK, Spain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.