Prytime Medical Devices, Inc. Recall 87099
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
Prytime Medical Devices, Inc. Recall 87099 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0959-2021 |
| Event ID | 87099 |
| Event 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 |
| Product Type | Devices |
| 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 |
| Recall 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. |
| Device Classification | 20210217 |
| Device Code Info | Lot # MFG 3590 |
| Center Classification Date | 20210205 |
| Recall Initiation Date | 20201214 |
| Recalling Firm | Prytime Medical Devices, Inc. |
| Initial Notification | Letter |
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