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.
FDA Recall Z-0716-2021 · Posted None
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Recalling FirmPrytime Medical Devices, Inc.
Recall StatusTerminated
Product CodeMJN
Date Initiated2020-10-29
Date Terminated2023-01-11
Product Quantity3 units
Reason for Recall
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.
Firm Action
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].
Root Cause
Labeling design
Distribution Pattern
US Nationwide distribution in the state of Utah.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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