Z-0716-2021Class II

PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer...

Name: Z-0716-2021 PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer...
Creator: Prytime Medical Devices, Inc.
Published: 2020-10-29
License: https://open.fda.gov/license/

Prytime Medical Devices, Inc. / initiated 2020-10-29 / Terminated / root cause: labeling and UDI

FDA source

Prytime Medical Devices, Inc. began a recall of PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001... on 2020-10-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0716-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-29
Posted: 2020-12-23
Terminated: 2023-01-11
Recalling firm: Prytime Medical Devices, Inc.
Product: 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.
Product code: MJN Catheter, Intravascular Occluding, Temporary
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
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].
Quantity in commerce: 3 units
Distribution: US Nationwide distribution in the state of Utah.
Product codes and lots: Lot # 205936

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0716-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0716-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23

Product code MJN

K193440Class IIER-REBOA PLUS CatheterPrytime Medical Devices, Inc. / cleared 2020-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)