BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
This recall has been terminated (originally issued September 17, 2018).
- Company
- Leica Microsystems, Inc.
- Recall Initiated
- September 17, 2018
- Terminated
- August 21, 2020
- Recall Number
- Z-0281-2019
- Quantity
- 876 devices (in U.S. and Canada)
- Firm Location
- Buffalo Grove, IL
- Official Source
- View on FDA website ↗
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
Distribution was nationwide. There was also government/military distribution. Foreign distribution was made to Canada.
Lot / Code Info
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).
Root Cause
Nonconforming Material/Component
Action Taken
The recalling firm issued letters dated 9/3/2018 via email on 9/17/2018. A second letter dated 9/24/2018 was issued to update the acknowledgment form to include the number of affected power supply units the consignee destroyed.