Z-1445-2017 Class II Terminated
FDA device recall Z-1445-2017 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: 250.
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
- 250
Product Description
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
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/Ex p. Date: RED1747 2018-09 RED1754 2018-12 RED1763 2019-03 RED1770 2019-05