NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSteri

FDA device recall Z-2035-2024 · posted 2024-06-07 · Open, Classified

Recall details

Recalling firm

Avanos Medical, Inc.

Reason for recall

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

Action taken

Avanos notified consignees via email or overnight FedEx on or about 03/04/2024. Consignees were instructed to locate affected product in their inventories by comparing the case packaging as demonstrated in the letters, and destroying it. An acknowledgment form was provided in order for them to record their inventory, and confirm destruction, to be returned to fieldactioncare@avanos.com. Replacement with unaffected Avanos NeoMed* Pharmacy Syringes Nonsterile (Non ENFit) will be provided to end users who report affected inventory. Distributors are asked to identify their affected customers and provide notification to them, as well as report theirs and their customers inventory to Avanos via the acknowledgment form.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KYX

Quantity affected

37,476 cases (16,704,600 units)

Distribution

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

Date initiated

2024-03-04

Date posted

2024-06-07

Location

Alpharetta, GA