Z-2305-2021Class II

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

Name: Z-2305-2021 WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
Creator: Delta Med SpA
Published: 2021-06-21
License: https://open.fda.gov/license/

Delta Med SpA / initiated 2021-06-21 / Open, Classified / root cause: manufacturing process

FDA source

Delta Med SpA began a recall of WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W on 2021-06-21. FDA classified it as Class II and gives the reason as "Problems related to the sterilization of the medical devices; possible missing sterility of the medical device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2305-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-21
Posted: 2021-08-16
Recalling firm: Delta Med SpA
Product: WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm disseminated the notices on 06/21/2021 by email. The firm is requesting destruction of the affected devices at the consignee.
Quantity in commerce: 40,000 units
Distribution: US Nationwide distribution in the states of FL and MN.
Product codes and lots: a) REF PIVD2010W, Lot 1100256 b) REF PIV2210W, Lot 1100316 c) REF PIV2475W, Lot 1200084

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2305-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2295-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2296-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2297-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2298-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2299-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2300-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2301-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2302-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2303-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2304-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2305-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16

Product code FOZ

K200373Class IIDeltaven Fast Flash Closed I.V. Catheter SystemsDelta Med Spa / cleared 2020-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)