Class 2 Device Recall REBOA Catheter Convenience Set

• Date Initiated by Firm: December 14, 2020
• Create Date: February 05, 2021
• Recall Status: Terminated on September 28, 2022
• Recall Number: Z-0959-2021
• Recall Event ID: 87099
• Product Classification: Catheter introducer kit - Product Code OFC
• Product: 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
• Code Information: Lot # MFG 3590
• FEI Number: 3014034613
• Recalling Firm/ Manufacturer: Prytime Medical Devices, Inc.; 229 N Main St; Boerne TX 78006-2035
• For Additional Information Contact: Brian Young; 210-340-0116
• Manufacturer 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.
• FDA Determined Cause: Mixed-up of materials/components
• Action: On 12/14/2020, Prytime Medical sent an "Urgent Medical Device Recall Notification" to affected consignees via FedEx. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1) Please immediately review your inventory for the recalled lot specified in this notification. Quarantine and do NOT use this lot. 2) If you have an urgent need for this kit, and dont have an alternative lot available then please ensure that you have a backup 18 gauge access needle readily available at the point of use. Do not use the 21G access needle in the kit. 3) Immediately complete and return the attached Customer Response Form to the contact on the form. a. Please specify the number of affected kits in your possession. b. Prytime will promptly contact you to arrange return and replacement shortly after receiving the completed form. 4) Share this recall notification with any users of the product within your facilities, or anyone else you may have sent the product to, in order to ensure they are also aware of this recall. 5) Report any adverse health consequences experienced with the use of this product to Prytime using the attached form, or by email at recall@prytimemedical.com, or by phone at (210) 340-0116. If you have any questions or discover any additional REBOA Convenience Set KT1835C Lot MFG3590 at your facility please contact the Recall Coordinator by phone at (210) 340-0116, or by email at recall@prytimemedical.com.
• Distribution: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.