FDAClass IIISeptember 26, 2018

Portex Pulsator Arterial Blood Sampling Kit with Dry recall: Labeling Error

Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label…

Why was Portex Pulsator Arterial Blood Sampling Kit with Dry recalled?

The product was mislabeled with the incorrect label.

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?

Lot numbers 3306404, 3314069, and 3318698.

Product
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label…
Recalling firm
Smiths Medical ASD Inc.
Quantity
29,600 kits
Distribution
US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.
Recall date
September 26, 2018
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls