Myelotec Video Guided Catheters Recalled for Defective Access Port Body
Myelotec, Inc. is recalling 2,980 Video Guided Catheters because a defective Access Port Body component can cause the port to become obstructed or blocked.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4).
Plain-English summary
Myelotec, Inc. is recalling 2,980 units of Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels. The recall is due to a defective VGC Access Port Body component that can result in an obstructed or blocked port.
The affected lots are 4123/MY33613, 4250/MY06614, 4279/MY06614, 4305/MY10814, 4331/MY13914, and 4331/MY25214. The products were distributed worldwide, including to the United States (CA, FL, KY, MN, and NJ) and to Brazil, Iran, Kuwait, Malaysia, Singapore, South Korea, Taiwan, and Turkey.
The FDA has classified this as a Class II recall. Healthcare providers and patients should stop using the affected devices and contact Myelotec, Inc. for instructions on returning the product.
The recalled product
- Product
- Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
- Manufacturer
- Myelotec, Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 2,980
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 (6)
- Lot No. 4123/MY33613
- 4250/MY06614
- 4279/MY06614
- 4305/MY10814
- 4331/MY13914
- and 4331/MY25214
Distribution
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