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KYXClass 1

Dispenser, Liquid Medication

FDA adverse event reports and recall history for dispenser, liquid medication (product code KYX), from the public MAUDE/AEMS corpus and the live FDA recall database.

Total reports
262
Deaths
3
Injuries
23
Malfunctions
203

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 20122026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

  • 2024-06-07Open, ClassifiedUnder Investigation by firm

    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, Product Code BA-S12EO; c. 1mL Oral Syringe Amber NonSterile, Product Code BA-S1EO; d. 20mL Oral Syringe Amber NonSterile, Product Code BA-S20EO; e. 35mL Oral Syringe Amber NonSterile, Product Code BA-S35EO; f. 3mL Oral Syringe Amber NonSterile, Product Code BA-S3EO; g. 60mL Oral Syringe Amber NonSterile, Product Code BA-S60EO; h. 6mL Oral Syringe Amber NonSterile, Product Code BA-S6EO;

    The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

  • 2024-06-07Open, ClassifiedUnder Investigation by firm

    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product Code BB-S12EO; c. 1mL Oral Syringe Blue NonSterile, Product Code BB-S1EO; d. 20mL Oral Syringe Blue NonSterile, Product Code BB-S20EO; e. 35mL Oral Syringe Blue NonSterile, Product Code BB-S35EO; f. 3mL Oral Syringe Blue NonSterile, Product Code BB-S3EO; g. 60mL Oral Syringe Blue NonSterile, Product Code BB-S60EO; h. 6mL Oral Syringe Blue NonSterile, Product Code BB-S6EO;

    The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

  • 2024-06-07Open, ClassifiedUnder Investigation by firm

    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO; b. 12mL Oral Syringe Orange NonSterile, Product Code BC-S12EO; c. 1mL Oral Syringe Orange NonSterile, Product Code BC-S1EO; d. 20mL Oral Syringe Orange NonSterile, Product Code BC-S20EO; e. 35mL Oral Syringe Orange NonSterile, Product Code BC-S35EO; f. 3mL Oral Syringe Orange NonSterile, Product Code BC-S3EO; g. 60mL Oral Syringe Orange NonSterile, Product Code BC-S60EO; h. 6mL Oral Syringe Orange NonSterile, Product Code BC-S6EO

    The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

  • 2023-04-20Open, ClassifiedUnder Investigation by firm

    ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe

    ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.

  • 2015-02-27TerminatedLabeling Change Control

    Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100, H938679025, H938679100, H938690025, H93869025, H938693025, H938696025, H93868025, H93868100, H938672025, H938672100, H938675025, H938675100, H938678025, and H938678100.

    Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels.

  • 2014-12-24TerminatedProcess control

    Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile

    Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation.

  • 2012-02-23TerminatedDevice Design

    BD Oral Dispensing Syringe Oral Syringe Tip Caps various sizes ( 1 mL, 3 mL, 5 mL. 10 mL BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com Ref Numbers 305207, 305218, 305210, 305220, 305208, 305218, 305219 Product Usage: Used for the oral administration of medications

    There are complaint reports for loose tip caps in various types of oral syringes

  • 2012-02-21TerminatedProcess control

    Children's Medical Ventures 1 ml Amber Oral Syringe. The product is a Liquid Medication Dispenser.

    The tip caps may come loose from the syringe, potentially resulting in leakage of medication from the syringe.

  • TerminatedMixed-up of materials/components

    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.

    Product is mislabeled as self-righting Luer slip tip caps, yellow.

  • Open, ClassifiedUnder Investigation by firm

    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF H93866025, b) 100 pack, REF H93866100, c) 25 pack, REF H938690025

    There is a potential of the packaging not maintaining a sterile barrier for the tip caps.

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