PowerPICC Catheter Kits Recalled for Incorrect Micro-Introducer Components
Bard Access Systems is recalling 180 units of 5Fr PowerPICC Catheter kits because they contain incorrect micro-introducers.
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 medical device recall involving a manufacturing defect where incorrect components were supplied. No illnesses or injuries are reported in the source text. As a risk-of-harm medical device without documented injury, it meets the criteria for 'High' severity per the rubric.
Plain-English summary
Bard Access Systems Inc. is recalling 5Fr PowerPICC Catheter Single-Lumen kits with 70cm guidewires. The affected product lot is REEU0201 (catalog number 3175155), with 180 units distributed.
The catheter kits were found to contain incorrect micro-introducers.
The affected devices were distributed to medical facilities in Connecticut, Georgia, Massachusetts, Michigan, Montana, New Jersey, Nevada, New York, Virginia, and Wisconsin.
The recalled product
- Product
- 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
- Manufacturer
- Bard Access Systems Inc.
- Category
- Medical Device — Vascular Access
- Affected units
- 180
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 (1)
- Catalog Number: 3175155 UDI Code: (01)00801741027680 Lot Number: REEU0201
Distribution
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