The Recall Desk
HighFDA (Devices)·Z-2297-2021·Announced 2021-08-25

IV Catheters recalled due to potential sterilization failure

229,320 DELTAVEN FASTFLASH IV catheters distributed in Florida and Minnesota are being recalled due to sterilization defects. The medical devices may not be sterile, posing contamination and infection risks to patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA medical device recall for sterilization defects in invasive IV catheters. Although no illnesses or injuries have been reported in the source text, non-sterile catheters pose a significant contamination and infection risk to patients, qualifying this as a risk-of-harm product.

Plain-English summary

DELTAVEN FASTFLASH Safety I.V. Catheters manufactured by Delta Med SpA are being recalled. The recall involves 229,320 units with multiple product reference numbers, distributed in Florida and Minnesota.

The recall is due to sterilization defects. The medical devices may not be sterile at the point of distribution, which could expose patients to contamination and infection risks.

Healthcare facilities and distributors in affected states should stop using the recalled lots immediately. Refer to the FDA recall notice for the specific product reference numbers and lot codes included in this recall. Contact Delta Med SpA or your distributor for additional information.

The recalled product

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)
Manufacturer
Delta Med SpA
Category
Medical Device — Intravenous Catheters
Hazard
  • sterilization-failure
  • contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

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