Z-0281-2019 Class II Terminated
FDA device recall Z-0281-2019 was initiated by Leica Microsystems, Inc. on September 17, 2018 and is designated Class II. Reason for recall: The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard because it could contain an improperly-mixed phosphorus compound. The recall status is terminated (terminated August 21, 2020). Affected quantity: 876 devices (in U.S. and Canada).
Recall Details
- Product Type
- Devices
- Report Date
- November 7, 2018
- Initiation Date
- September 17, 2018
- Termination Date
- August 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 876 devices (in U.S. and Canada)
Product Description
BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
Reason for Recall
The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard because it could contain an improperly-mixed phosphorus compound.
Distribution Pattern
Distribution was nationwide. There was also government/military distribution. Foreign distribution was made to Canada.
Code Information
Zebra Printer Model TLP3842 - Affected PSU Part Number 808113-001 or P1028888-001 with date codes ranging from 0639XX through 1253XX (YYWWXX, where YY=year and WW=week); Zebra Printer Model GX4301 - Affected PSU Part Number 808101-001 with date codes ranging from 0639XX through 1253XX (YYWWXX, where YY=year and WW=week).