Access Scientific Recalls Mislabeled Powerwand XL Maximum Barrier Kits
Access Scientific LLC is recalling 1,710 Powerwand XL kits due to incorrect catheter length labels. The error may cause treatment delays or user annoyance.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The source text explicitly states the hazard is limited to treatment delays and user annoyance, fitting the 'Low' severity criteria for documentation or labeling issues.
Plain-English summary
Access Scientific LLC is recalling 1,710 units of the Powerwand XL 4Fr 8cm Maximum Barrier Kit. The affected products are identified by Catalog No. 94108 and lot numbers 269939, 270552, 270874, and 272261. These kits were distributed nationwide in the United States, including New York.
The recall was initiated because the convenience kits were mislabeled with the incorrect catheter effective length on both the device and packaging labels. The FDA has classified this as a Class III recall, indicating that the labeling error is unlikely to cause adverse health consequences.
The use of these mislabeled kits may lead to a delay or interruption of treatment, as well as user dissatisfaction or annoyance. No injuries or illnesses have been reported in connection with this recall. Consumers and healthcare providers should stop using the affected kits and contact Access Scientific LLC for further instructions.
The recalled product
- Product
- POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain…
- Manufacturer
- Access Scientific LLC
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 1,710
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)
- Lot number 269939
- 270552
- 270874
- and 272261.
Distribution
Related recalls
Same manufacturer · Access Scientific LLC
See all →- HighAccess Scientific Recalls Saline Flush Syringes Due to Packaging Holes
FDA (Devices) · 2020-05-20
- HighAccess Scientific Recalls Saline Flush Syringes Due to Packaging Holes
FDA (Devices) · 2020-05-20
- HighAccess Scientific Recalls Saline Flush Syringes Due to Packaging Defects
FDA (Devices) · 2020-05-20
- HighAccess Scientific Recalls Saline Flush Syringes Due to Packaging Holes
FDA (Devices) · 2020-05-20
- HighAccess Scientific Recalls Saline Flush Syringes Due to Packaging Holes
FDA (Devices) · 2020-05-20
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
Similar recalls
- ModerateAccess Scientific Recalls Mislabeled POWERWAND Safety Introducer Catheters
FDA (Devices) · 2013-09-25
- HighAccess Scientific Recalls Saline Flush Syringes Due to Packaging Defects
FDA (Devices) · 2020-05-20
- HighAccess Scientific Recalls Saline Flush Syringes Due to Packaging Holes
FDA (Devices) · 2020-05-20
- HighHydroMID 4Fr Peripheral Venous Catheter Kit Recalled for Incorrect Component Labeling
FDA (Devices) · 2023-03-01
- HighBard PowerPICC Catheter Kits Recalled for Wrong Guidewire Size
FDA (Devices) · 2021-07-07
- HighHydroMID 4Fr Catheters Recalled for Incorrect Expiration Dating
FDA (Devices) · 2023-02-22