Reported Jun 16, 2021 · Terminated

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…

Smiths Medical ASD Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690

Is this the product you have?

  • JELCO HYPODERMIC
  • NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGEa) 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
Lot codes and dates
  • a) REF 4428-1
  • Lot Numbers4046543 and 4062235 b) REF 4429-1
  • Lot Numbers
    • 4031846
    • 4031845
    • 4040734
    • 4043536
    • 4046545
    • 4046546
    • 4062239
    • 4062240
    • 4062238
    • 4062242
    • 4014096
Amount recalled
1,432,200 units

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 11, 2023 · Data as of Sep 19, 6:20 PM UTC

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