LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.
This recall has been terminated (originally issued June 3, 2013).
- Company
- Leica Microsystems, Inc.
- Recall Initiated
- April 4, 2013
- Posted
- June 3, 2013
- Terminated
- July 21, 2017
- Recall Number
- Z-1446-2013
- Quantity
- 20,160 units
- Firm Location
- Buffalo Grove, IL
- Official Source
- View on FDA website ↗
Reason for Recall
An LPC Fine Mesh Cassette failed to stay closed during processing operations.
Distribution
Worldwide distribution: US (nationwide) to states of AZ and KY; and the country of New Zealand.
Lot / Code Info
1) Part No.: 14060546848; Batch No.s: 8280-10309, 82801-0310; 2) Part No.: 14060546846; Batch No.s: 1034710114; 3) Part No.: 14060546845; Batch No.s: 1021420914; 4) Part No.: 14060546933; Batch No.s: 82801-0217; 5) Part No.: 14060546932; Batch No.s: 1030730112, 1101110204; 6) Part No.: 14060546852; Batch No.s: 1101910322; 7) Part No.: 14060546850; Batch No.s: 1034710204, 1034710328, 1113910803; 8) Part No.: 14060546847; Batch No.s: 913920827
Root Cause
Device Design
Action Taken
A Medical Device Correction letter dated April 17, 2013 was sent to customers via USPS 1st class mail. The product issue was described and recommended actions were provided. Customers were requested to acknowledge receipt of the letter by fax-back. Customer questions were directed to (847) 405-5413.