HydroPICC Basic Kit (130cm GW) 80001001Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K193015); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Dec 16, 2022Open, Classified

   Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

   Z-1131-2023 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193015. One submission often covers many models, so check the product and lot details in each record.

• Z-1605-2023 · Mar 3, 2023 · Open, Classified
  HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
• Z-1130-2023 · Dec 16, 2022 · Open, Classified
  HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
• Z-0199-2023 · Feb 24, 2021 · Terminated
  Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter