FDAClass IMay 15, 2013

A) Presource PBDS recall

A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit

Why was A) Presource PBDS recalled?

Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

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?

A) Catalog Number: PG24LCGWG02; Lots: 153502, 162892, 170494, 180482, , 88701, 193548, 198163, 206986; B) Catalog Number: PG24LCGWG; Lots:153502, 162892, 170494, 180482, 188701, 193548, 198163, 206986

Product
A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit
Recalling firm
Cardinal Health, Medical Products & Services
Quantity
4,571 Kits total
Distribution
Distributed in the states of AR, MS, SC, and TN.
Recall date
May 15, 2013
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls