Data Foundry

Medical device recalls 2022

Scalpel and StatLock included with HydroPICC Catheter Kit — Class II medical device recall Z-0199-2023

Terminated recall by Access Vascular, Inc., reported 2022-11-16, distributed in IL, NC, NJ, RI. Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiratio

Recall numberZ-0199-2023
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAccess Vascular, Inc., Billerica, MA, United States
Recall initiated2021-02-24
Classified2022-11-07
Reported by FDA2022-11-16
Terminated2024-05-30
DistributedIL, NC, NJ, RI
Quantity79 kits
UPC / GTIN / UDI-DI00862559000418
Lot numbers09112001, 10212001, 10282001, AUG-22, FEB-21, JUN-21, R18-08-010, R18-09-008, R19-01-009, R20-01-010
Expiration dates2021-05-28, 2021-09-24, 2021-10-21, 2021-11-18

Product

Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter

Reason for recall

Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.

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-0199-2023. 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.