Z-1452-2017 Class II Terminated
FDA device recall Z-1452-2017 was initiated by LeMaitre Vascular, Inc. on February 7, 2017 and is designated Class II. Reason for recall: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch The recall status is terminated (terminated September 20, 2019). Affected quantity: 2065.
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2017
- Initiation Date
- February 7, 2017
- Termination Date
- September 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2065
Product Description
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53
Reason for Recall
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Distribution Pattern
Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
Code Information
Lot Number/Exp. Date: RST2392 2018-09 RST2400 2018-10 RST2408 2018-12 RST2419 2019-04 RST2431 2019-04 RST2436 2019-05 RST2447 2019-08