Skip to content
Recall Observatory FDA recall evidence

Device product

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;

Z-2035-2024

March 04, 2024

Class III

Product summary

Firm
Avanos Medical, Inc.
Event
Event 94518
Status
Ongoing
Classification
Class III
Quantity
37,476 cases (16,704,600 units)
Official record key
device-enforcement:Z-2035-2024

Official wording

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

Code information: a. UDIDI 00350770002798, all lot numbers; b. UDIDI 00350770002835, all lot numbers; c. UDIDI 00350770002804, all lot numbers; d. UDIDI 00350770002842, all lot numbers; e. UDIDI 00350770002859, all lot numbers; f. UDIDI 00350770002811, all lot numbers; g. UDIDI 00350770002866, all lot numbers; h. UDIDI 00350770002828, all lot numbers;

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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

Field note

Send feedback

We'll only use this to respond to your feedback.