ROTEM ex-tem Canada Part No: 503-05-CA
Recall
- Recall Number
- Z-2486-2019
- Event Number
- 83523
- Firm
- Instrumentation Laboratory Co.
- FEI Number
- 1217183
- Product Code
- JPA
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- July 23, 2019
- Terminated
- April 27, 2020
- Address
- 180 Hartwell Rd, Bedford, MA, 01730-2443
Description
ROTEM ex-tem Canada Part No: 503-05-CA
Prolonged clotting times
-Check your inventory for Lot No. 42255901 / 42255801 and destroy all remaining material. - Document the destruction on the Mandatory Tracking Response Record and return the completed and signed form to the fax number or e-mail address listed on the next page. -Contact your local representative for an alternative product lot of ROTEM ex-tem, Part No. 503-05-US / 503-05-CA. -Share this information with your laboratory staff and follow your internal procedures. -Forward this notification to all affected locations within your facility. -Retain a copy of this notification for your records. -Return the completed and signed form confirming lot destruction and quantities to: FAX No. 781-861-4207 or Email: [email protected] For Technical Questions: Call ROTEM PBM Technical Support Center at 1-800-678-0710, Option # 4 For Replacement Lot: Call IL Customer Service Center at 1-800-955-9525, Option # 0
States: IL WI MI Canada, Spain, Portugal, Poland, Italy, Israel, Switzerland, Denmark, Kazakhstan, United Kingdom, Germany, Netherlands, Belgium, France, Jordan, India, Hong Kong, Austria, Czechia, Australia, Sri Lanka, Argentina, Vietnam, Singapore, Japan, South Korea, Cyprus, Ireland, Hungary, Sweden, Serbia.
44 kits