The Recall Desk
SevereFDA (Devices)·Z-2779-2017·Announced 2017-08-09

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.

What this means for you

Illness, injury, or structural failure has been reported. 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

Distributed in 5 states:

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