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Terminated

ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.

FDA Recall Z-1379-2015 · Posted 2015-04-03

Recalling FirmTEM Systems Inc
Recall StatusTerminated
Product CodeJPA
Date Initiated2014-10-23
Date Terminated2015-08-13
Product QuantityTotal 1574 x 5 vials per box

Reason for Recall

Some of vials were found to be partially filled.

Firm Action

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: [email protected] 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

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101533EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEMTem Innovations GmbH · 2011-08-10K083842ROTEM DELTA THROMBOELASTOMETRY SYSTEMPentapharm GmbH · 2010-03-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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