RecallRadar

FDA Device recall Z-2303-2021

NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822

On 2021-08-25 the FDA classified a Class II recall of NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822 by Delta Med Spa, citing problems related to the sterilization of the medical devices; possible missing sterility of the medical device.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2303-2021
ClassificationClass II
Statusongoing
Initiated2021-06-21
Published2021-08-25
Last updated2026-09-13 11:56 UTC
CompanyDelta Med Spa
DistributionUS

Product

NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822

Reason

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

Identifiers

code_infoa) REF 3738522, Lot 00A2160813 b) REF 3738822, Lot 00A1160822

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2303-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.