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Prytime Medical Devices, Inc.

Prytime Medical Devices, Inc. · Model KT1835C · UDI-DI 00863092000101

OFCPXB Prescription
1
510(k) clearances
105
Adverse events
4
Recalls
26
Facilities

Description

REBOA Catheter Convenience Set

Recalls

DateFirmReason
2026-04-21ARROW INTERNATIONAL, LLCLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo
2026-03-11ARROW INTERNATIONAL, LLCDue to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
2026-03-11ARROW INTERNATIONAL, LLCDue to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
2020-12-14Prytime Medical Devices, Inc.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 guid

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.