FDAClass IIAugust 14, 2019

Regard ¿ custom surgical pack labeled as "LAP - FLOL recall

Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II…

Why was Regard ¿ custom surgical pack labeled as "LAP - FLOL 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): 800096004 (044343D, 43590); 800096004 (048023D, 43722); 800096004 (049262D, 43757); 800096004 (052020D , 43856); 800096004 (054482D, 43948); 800096004 (057619D, 44035); 800096005 (059908E , 44080); 800096005 (062938E , 44151); 800096005 (65606E, 44232);

Product
Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II…
Recalling firm
ROi Consolidated Service Center (CSC)
Quantity
261 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