Z-0959-2021 Class II Terminated
FDA device recall Z-0959-2021 was initiated by Prytime Medical Devices, Inc. on December 14, 2020 and is designated Class II. 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 th… The recall status is terminated (terminated September 28, 2022). Affected quantity: N/A.
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