PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.
Recall
- Recall Number
- Z-0716-2021
- Event Number
- 86797
- Firm
- Prytime Medical Devices, Inc.
- FEI Number
- 3014034613
- Product Code
- MJN
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- October 29, 2020
- Terminated
- January 11, 2023
- Address
- 229 N Main St, Boerne, TX, 78006-2035
Description
PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.
There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result in a procedure delay or injury to the patient.
On October 29, 2020 the firm sent an "Urgent Medical Device Recall Notification" letter to consignees via FedEx. In addition to informing the consignees about the recall, the firm ask customers to take the following actions: 1. Please immediately quarantine and do NOT use the affected lot. 2. A Prytime representative will visit your facility and retrieve the units from the affected lot from you at that time, and return them. 3. If you have any questions or discover any additional ER-REBOA PLUS Catheters from Lot 205936 please contact me by phone at (210) 340-0116, or by email at [email protected].
US Nationwide distribution in the state of Utah.
3 units