Home / Recalls / Delta Med SpA / Z-2301-2021

Z-2301-2021 Class II Ongoing

Recalled by Delta Med SpA — Viadana, N/A

FDA device recall Z-2301-2021 was initiated by Delta Med SpA on June 21, 2021 and is designated Class II. Reason for recall: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device The recall status is ongoing. Affected quantity: 20,000 units.

Recall Details

Product Type
Devices
Report Date
August 25, 2021
Initiation Date
June 21, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20,000 units

Product Description

NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522

Reason for Recall

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

Distribution Pattern

US Nationwide distribution in the states of FL and MN.

Code Information

a) REF 3779422, Lot 00A1160635 b) REF 3769522, Lot 00A1160656 c) REF 3708522, Lot 00A1160638

Other recalls by Delta Med SpA

  • Z-2303-2021 Class II — NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822 (June 21, 2021)
  • Z-2295-2021 Class II — DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF (June 21, 2021)
  • Z-2297-2021 Class II — DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814 (June 21, 2021)
  • Z-2296-2021 Class II — DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 (June 21, 2021)
  • Z-2299-2021 Class II — NEO DELTA Self Safe, I.V. Catheter REF 3738222 (June 21, 2021)
  • Z-2300-2021 Class II — NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 (June 21, 2021)
  • Z-2305-2021 Class II — WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) RE (June 21, 2021)
  • Z-2298-2021 Class II — DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) R (June 21, 2021)
  • Z-2304-2021 Class II — NEO DELTA SELFSAFE PUR T, I.V. Catheter: (June 21, 2021)
  • Z-2302-2021 Class II — NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122 (June 21, 2021)

FDA data resources