Ultima OPCAB System recall: Labeling Error
Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy…
Why was Ultima OPCAB System recalled?
MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling for the 2 blade lots had been incorrectly applied. The standard blades from Lot #25052176 were incorrectly labeled as deep blades, and the 20 deep blades from Lot #25052200 were incorrectly labeled as standard blades.
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?
ULTIMA OPCAB System Part Nos. OM-2003S (LOT #25052176) and OM-2001D (LOT #25052200).
- Product
- Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy…
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- 20 units (Lot 25052176); 12 units (Lot #25052200)
- Distribution
- USA Nationwide Distribution in the states of: Florida, Maryland, New Jersey, New York and Texas.
- Recall date
- October 9, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)