Centurion Medical Recalls Port Access Kits Due to Needle Issue
Centurion Medical Products Corporation is recalling 11,260 Port Access Kits distributed in Illinois. The recall was initiated by the supplier due to an issue with GRIPPER Needles.
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 medical device with an unspecified defect in a critical component (needles). Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Centurion Medical Products Corporation is recalling 11,260 units of the Kit, Port Access (Product Code: DYNDC1582A). The affected products were distributed in Illinois. The recall was initiated by the supplier and involves an issue with the GRIPPER Needles included in the kits.
The recall covers specific lots with expiration dates ranging from August 31, 2020, to April 30, 2021. The affected lot numbers are 2018121350, 2019020750, 2019031550, 2019041550, 2019061750, and 2019062450.
The source text does not specify the exact nature of the defect or the potential health risks associated with the GRIPPER Needles. No injuries or illnesses have been reported in the provided text. Healthcare facilities and consumers should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- Kit, Port Access Product Code: DYNDC1582A
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 11,260
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Centurion Medical Products Corporation 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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