ClearanceBrief
Recall Z-2301-2021 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Delta Med SpA

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

DateJun 21, 2021
StatusOpen, Classified
ReasonProblems related to the sterilization of the medical devices; possible missing sterility of the medical device
Root causeProcess control
ActionThe firm disseminated the notices on 06/21/2021 by email. The firm is requesting destruction of the affected devices at the consignee.
Quantity20,000 units
DistributionUS Nationwide distribution in the states of FL and MN.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K121007NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1
Delta Med Srl, Dec 28, 2012