Recall Z-2305-2021— Delta Med SpA

Name: FDA recall Z-2305-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-21

Class II · Ongoing

Class II FDA medical device recall by Delta Med SpA, initiated 2021-06-21. It names one FDA 510(k) clearance: K200373. Product: WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W. Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device.

Recalling firm: Delta Med SpA
Classification: Class II
Status: Ongoing
Initiated: 2021-06-21
Firm location: Viadana, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K200373 — Deltaven Fast Flash Closed I.V. Catheter SystemsDelta Med Spa·cleared 2020-08-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

Reason for recall

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

Data sourced from openFDA. This site is unofficial and independent of the FDA.