ROTROL P Control for ROTEM delta Thromboelastometry recall
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Why was ROTROL P Control for ROTEM delta Thromboelastometry recalled?
Some of vials were found to be partially filled.
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?
Article number 503-25 (US ROTROL P), Lot no. 41819801, exp date 2016-11 and Lot no. 41855701, exp date 2017-06.
- Product
- ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
- Recalling firm
- TEM Systems Inc
- Quantity
- Total 1574 x 5 vials per box
- Distribution
- Nationwide Distribution
- Recall date
- April 15, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)