FDAClass IIApril 6, 2022

BALLARD* Multi-Access Port recall

BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use

Why was BALLARD* Multi-Access Port recalled?

Product was distributed with incorrect expiration date.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Finished Product Code: 102007202; Alternate Code: 240168-5; Lot No.: 30135997, 30137462, 30138710, 30140310, and 30141359.

Product
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
Recalling firm
Avanos Medical, Inc.
Quantity
2,520 devices (126 cases)
Distribution
Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.
Recall date
April 6, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls