DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF
Summary
The FDA issued a Class II for DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 by Delta Med SpA. Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device.
Details
Source
Device Recall
External ID
Z-2296-2021
Action Date
2021-08-25
Status
Ongoing
Category
device
Product Description
DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
Lot/Code Info: a) REF 3832572: Lot 11T80189 b) REF 3842572, Lot 11T80198 c) REF 3821572, Lot 11T80149 d) REF 3833572, Lot 11T80292 e) REF 3831572, Lot 12T80230 f) REF 3810572, Lot 12T80302 g) REF 3852572, Lot 12T80349
Quantity Affected: 203,680 units
Reason for Recall
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Distribution
US Nationwide distribution in the states of FL and MN.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-21
Company
Viadana, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 221 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Delta Med SpA has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Delta Med SpA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Delta Med SpA have FDA actions?
Delta Med SpA has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2296-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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