PryTime Medical — Class II medical device recall Z-0716-2021
Terminated recall by Prytime Medical Devices, Inc., reported 2020-12-30, distributed nationwide. There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result
| Recall number | Z-0716-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Prytime Medical Devices, Inc., Boerne, TX, United States |
| Recall initiated | 2020-10-29 |
| Classified | 2020-12-23 |
| Reported by FDA | 2020-12-30 |
| Terminated | 2023-01-11 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Lot numbers | 205936 |
| Model numbers | ER7232PLUS |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0716-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.