Home / Recalls / Prytime Medical Devices, Inc. / Z-0959-2021

Z-0959-2021 Class II Terminated

Recalled by Prytime Medical Devices, Inc. — Boerne, TX

Recall Details

Product Type: Devices
Report Date: February 17, 2021
Initiation Date: December 14, 2020
Termination Date: September 28, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Product Description

PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5 FR, STERILE, 1 EA, SCALPEL, #11SS, STERILE, 1 EA, SUTURE, NYLON, 18", 2-0, REVERSE CUTTING, STERILE 1 EA, THREE QUARTER DRAPE, STERILE 1 EA, INSERT, SALINE 1 EA, INSERT, CLAMP 1 EA UDI: (01) 0 0863092 00010 1

Reason for Recall

There is a potential that a catheter convenience set contains a 21G access needle instead of the correct 18G needle. If the 21G needle is used to gain vascular access then the guidewire included in the kit will not pass through the access needle to facilitate insertion of an introducer sheath and could therefore cause procedure delay or injury.

Distribution Pattern

US Nationwide distribution including in the states of NJ, NY, CA, TX, MI, MO, CO, MI, VA, DE, TN, MO, MT, AZ, FL, WI, SC, WA, TX, CT, IN, PA, ME, WI, MA, GA, OH, AR, UT, NY OUS: None

Code Information

Lot # MFG 3590