FDAClass IIAugust 14, 2019

Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC recall

Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset…

Why was Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC recalled?

Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Item Number (Lot Number, Expiration Date): 880341004 (043444D, 43566); 880341005 (047474E, 43706); 880341005 (049043E, 43750);

Product
Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset…
Recalling firm
ROi Consolidated Service Center (CSC)
Quantity
312 packs
Distribution
Distributed to LA and MO
Recall date
August 14, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls