Arrow Endurance Peripheral Catheter Systems Recalled for Missing Safety Latch
Arrow International is recalling specific lots of Endurance Extended Dwell Peripheral Catheter Systems because they may be missing a safety latch designed to prevent sharps injuries.
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: The recall involves a risk-of-harm product (sharps injury) where the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Arrow International Inc is recalling 305 units of ARROW ENDURANCE Extended Dwell Peripheral Catheter Systems. The affected products are Catalog Numbers EDC-00820 and EDC-00820-B. The recall involves specific lots: EDC-00820 (Lot 14X17C0039, expires February 2019) and EDC-00820-B (Lot 13F17F0120, expires May 2019).
The recall is being conducted because certain lots of these peripheral catheter systems may be missing the safety latch. This component is intended to minimize the risk of sharps injuries to healthcare workers or patients.
The affected units were distributed in the following U.S. states: Colorado, Florida, Illinois, North Carolina, Pennsylvania, South Carolina, and Texas. Healthcare facilities and consumers should check their inventory for these specific catalog numbers and lot numbers. If the safety latch is missing, the devices should be removed from service and returned to Arrow International Inc.
The recalled product
- Product
- ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 305
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)
- Catalog Number: EDC-00820
- Lot: 14X17C0039 (Expires February 2019)
- Catalog Number: EDC-00820-B
- Lot: 13F17F0120 (Expires May 2019)
Distribution
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