TEM Systems Recalls ROTROL P Control Vials Due to Partial Filling
TEM Systems Inc is recalling specific lots of ROTROL P Control vials because some were found to be partially filled.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a quality defect (partial filling) without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
TEM Systems Inc is voluntarily recalling specific lots of ROTROL P Control for the ROTEM delta Thromboelastometry System. The recall was initiated because some of the vials were found to be partially filled. The affected product is manufactured for Tem Innovations GmbH.
The recall covers 1,574 boxes, with each box containing five vials. The affected lots are identified by lot number 41819801 with an expiration date of November 2016, and lot number 41855701 with an expiration date of June 2017. The product was distributed nationwide.
Consumers and healthcare facilities should stop using the affected vials and contact TEM Systems Inc for further instructions or a refund.
The recalled product
- Product
- ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
- Manufacturer
- TEM Systems Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Article number 503-25 (US ROTROL P)
- Lot no. 41819801
- exp date 2016-11 and Lot no. 41855701
- exp date 2017-06.
Distribution
Distributed nationwide across the United States.
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