Recall Z-2297-2021
Delta Med SpA · initiated June 21, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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
Reason for recall
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
FDA-determined cause: Process control
Action taken
The firm disseminated the notices on 06/21/2021 by email. The firm is requesting destruction of the affected devices at the consignee.
Details
- Recall number
- Z-2297-2021
- Initiated
- June 21, 2021
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Quantity
- 229,320 units
- Distribution
- US Nationwide distribution in the states of FL and MN.
- Recalling firm
- Delta Med SpA, Viadana
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2295-2021 Class II | DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272…Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2296-2021 Class II | DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF…Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2298-2021 Class II | DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072…Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2299-2021 Class II | NEO DELTA Self Safe, I.V. Catheter REF 3738222Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2300-2021 Class II | NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 unitsProblems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2301-2021 Class II | NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2302-2021 Class II | NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2303-2021 Class II | NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2304-2021 Class II | NEO DELTA SELFSAFE PUR T, I.V. Catheter:Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2305-2021 Class II | WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475WProblems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |