Recall Z-0959-2021 ยท OFC Catheter Introducer Kit
Prytime Medical Devices, Inc.
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 D
| Date | Dec 14, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.