ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
FDA device recall Z-1379-2015 · posted 2015-04-03 · Terminated
Recall details
- Recalling firm
- TEM Systems Inc
- Reason for recall
- Some of vials were found to be partially filled.
- Action taken
- Tem sent an Dear Customer letter dated October 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You are entitled to return products delivered to you in the event that they are defective or otherwise not in conformity with your order when you received them. If you observe a low level of diluent in a box of Rotrol P lot number 41819801 at your location, please contact us for a free of charge replacement box from a new lot of Rotrol P. You can reach us at: Email: support@roteminc.com Phone: 919-941-7777, Option 2 Toll Free: 1-866-597-1652, Option 2 We apologize for any inconvenience you may experience.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JPA
- Quantity affected
- Total 1574 x 5 vials per box
- Distribution
- Nationwide Distribution
- Date initiated
- 2014-10-23
- Date posted
- 2015-04-03
- Date terminated
- 2015-08-13
- Location
- Durham, NC
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM (K101533) | Tem Innovations GmbH | 2011-08-10 |
| ROTEM DELTA THROMBOELASTOMETRY SYSTEM (K083842) | Pentapharm GmbH | 2010-03-23 |