Delta Med SpA: Medical Device Recall in 2021 - (Recall #: Z-2305-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 21, 2021

Date Posted: August 25, 2021

Recall Number: Z-2305-2021

Event ID: 88234

Reason for Recall:

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

Status: Ongoing

Product Quantity: 40,000 units

Code Information:

a) REF PIVD2010W, Lot 1100256 b) REF PIV2210W, Lot 1100316 c) REF PIV2475W, Lot 1200084

Distribution Pattern:

US Nationwide distribution in the states of FL and MN.

Voluntary or Mandated:

Voluntary: Firm initiated