HydroPICC Catheter Recall Due to Incorrect Expiration Dates on Select Lots
Select lots of HydroPICC 4Fr catheters are mislabeled with expiration dates that exceed their actual expiration. Affected units should not be used.
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: The mislabeling of expiration dates creates a risk-of-harm situation where expired medical devices could be inadvertently used. Although no illnesses or injuries have been reported, the use of expired catheters could result in device failure and patient harm.
Plain-English summary
Access Vascular, Inc. is recalling certain HydroPICC 4Fr Single Lumen, 80cm Guidewire Basic Kit (Model 80001002) due to incorrect labeling of expiration dates. Select lots were identified where the labeled expiration date extends beyond the actual expiration date of the catheters, creating a risk that expired devices could be used clinically.
The recalled lots are identified by UDI-DI (01)00862559000463 with lot numbers 11389279 and 11391525. The product was distributed nationwide in Connecticut, Illinois, Indiana, Massachusetts, Nebraska, Tennessee, and Texas.
Healthcare facilities that received these lots should not use the affected catheters and should ensure proper disposal and replacement. Users with questions should contact Access Vascular, Inc. directly for guidance on returns or replacements.
The recalled product
- Product
- HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
- Manufacturer
- Access Vascular, Inc
- Category
- Medical Device — Catheter
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 (3)
- UDI-DI: (01)00862559000463
- Lot Number: 11389279
- 11391525
Distribution
Part of a larger recall action
This product is one of 3 recalled by Access Vascular, Inc 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.
See all 3 products in this recall →Related recalls
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