Product Safety Recalls

Product Recall Tracker

Merit Medical Systems, Inc. Recall 88352

Description: MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391

Merit Medical Systems, Inc. Recall 88352 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2243-2021
Event ID88352
Event DescriptionMERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of ID, HI, TX, CA, AZ, MN, UT, KS, MO and the countries of Republic of Korea, Netherlands, Germany, Cyprus, Italy, Sweden, Taiwan, and Spain.
Quantity373 UNITS
Recall ReasonThere is a potential that a package sheath contains an incorrect dilator.
Device Classification20210818
Device Code InfoLot # H2069291
Center Classification Date20210812
Recall Initiation Date20210721
Recalling FirmMerit Medical Systems, Inc.
Initial Notification Letter
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.