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Class 2 Device Recall DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system |
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| Date Initiated by Firm |
June 21, 2021 |
| Create Date |
August 16, 2021 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2297-2021 |
| Recall Event ID |
88234 |
| 510(K)Number |
K171530
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| Product Classification |
Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
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| Product |
DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system:
a) REF 3814773
b) REF 3835773
c) REF 3825773
d) REF 3837773
e) REF 3846773
f) REF 3831473
g) REF 3842473
h) REF 3821473
i) REF 3832473
j) REF 3833473
k) REF 3821573
l) REF 3831573
m) REF 3833573
n) REF 3824773
o) REF 3804773
p) REF 3845773
q) REF 3811473
r) REF 3836773
s) REF 3843473
t) REF 3800473
v) REF 3842573
w) REF 3832573
x) REF 3847773
y) REF 3800573 |
| Code Information |
a) REF 3814773, Lot 11T00118 b) REF 3835773, Lot 11T00119 c) REF 3825773, Lot 11T00120 d) REF 3837773, Lot 11T00121 e) REF 3846773, Lot 11T00122 f) REF 3831473, Lot 11T00142 g) REF 3842473, Lot 11T00143 h) REF 3821473, Lot 11T00146 i) REF 3832473, Lot 11T00147 j) REF 3833473, Lot 11T00148 k) REF 3821573, Lot 11T00177 l) REF 3831573, Lot 11T00178 m) REF 3833573, Lot 11T00179 n) REF 3824773, Lot 11T00230 o) REF 3804773, Lot 11T00231 p) REF 3845773, Lot 11T00232 q) REF 3811473, Lot 11T05089 r) REF 3836773, Lot 11T05136 s) REF 3843473, Lot 11T05166 t) REF 3800473, Lot 11T10007 v) REF 3842573, Lot 12T00180 w) REF 3832573, Lot 11T10015 x) REF 3847773, Lot 11T10016 y) REF 3800573, Lot T1010018 |
Recalling Firm/
Manufacturer |
Delta Med SpA
Via Guido Rossa 20
Viadana Italy
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Manufacturer Reason
for Recall |
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
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FDA Determined
Cause 2 |
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 |
229,320 units |
| Distribution |
US Nationwide distribution in the states of FL and MN. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database |
510(K)s with Product Code = FOZ and Original Applicant = Delta Med SpA
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