Microline Surgical Recalls ReNew Dolphin Nose Disposable Dissector Tips
Microline Surgical is recalling specific lots of ReNew Dolphin Nose Disposable Dissector Tips due to a potentially compromised sterile barrier.
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 a potentially compromised sterile barrier, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Microline Surgical, Inc. is recalling certain lots of ReNew Dolphin Nose Disposable Dissector Tips, Catalog Number 3312. These single-patient-use disposable tips are designed to be used with ReNew Laparoscopic Hand Pieces for cutting, grasping, dissecting, and coagulation of tissue during endoscopic and laparoscopic surgical procedures.
The recall is being conducted because the affected lots may potentially have a compromised sterile barrier. The specific lots involved are 70208, 70209, and 70210, identified by UDI 00811099011989. The product was distributed in boxes of 10 tips each.
The affected products were distributed in the U.S. states of Florida, Massachusetts, Michigan, Ohio, Oklahoma, and Tennessee, as well as in the Netherlands. Healthcare facilities and consumers should stop using these specific lots and contact Microline Surgical for further instructions.
The recalled product
- Product
- ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in…
- Manufacturer
- Microline Surgical, Inc.
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 (3)
- Lot Numbers: 70208
- 70209
- 70210 UDI: 00811099011989
Distribution
Part of a larger recall action
This product is one of 2 recalled by Microline Surgical, Inc. 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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