RecallRadar

FDA Device recall Z-1452-2017

LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53

On 2017-03-22 the FDA classified a Class II recall of LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53 by Lemaitre Vascular, citing the Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1452-2017
ClassificationClass II
Statusterminated
Initiated2017-02-07
Published2017-03-22
Last updated2026-09-13 11:54 UTC
CompanyLemaitre Vascular
DistributionUS

Product

LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53

Reason

The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch

Identifiers

code_infoLot Number/Exp. Date: RST2392 2018-09 RST2400 2018-10 RST2408 2018-12 RST2419 2019-04 RST2431 2019-04 RST2436 2019-05 RST2447 2019-08

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1452-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.