FDA Recalls WOLF-PAK IV Catheters Due to Sterilization Problems
Delta Med SpA is recalling WOLF-PAK Self Safe Safety IV Catheters due to sterilization defects affecting approximately 40,000 units in Florida and Minnesota.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 an FDA Class II recall for sterilization defects in IV catheters. Although no illnesses or injuries have been reported, compromised sterility poses a significant infection risk as a direct-contact medical device. This meets the rubric criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Delta Med SpA is recalling WOLF-PAK Self Safe Safety IV Catheters due to sterilization problems and the possible missing sterility of the devices. The recall covers three reference numbers—REF PIVD2010W (Lot 1100256), REF PIV2210W (Lot 1100316), and REF PIV2475W (Lot 1200084)—totaling approximately 40,000 units distributed in Florida and Minnesota.
Sterilization defects or compromised sterility in IV catheters pose an infection risk to patients. The FDA classifies this recall as a Class II issue. Healthcare facilities should verify lot numbers of their WOLF-PAK catheters and discontinue use of affected units. Consult Delta Med SpA for instructions regarding return or replacement of recalled products.
The recalled product
- Product
- WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
- Manufacturer
- Delta Med SpA
- Category
- Medical Device — IV Catheter
- Affected units
- 40,000
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 (4)
- a) REF PIVD2010W
- Lot 1100256 b) REF PIV2210W
- Lot 1100316 c) REF PIV2475W
- Lot 1200084
Distribution
Part of a larger recall action
This product is one of 11 recalled by Delta Med SpA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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