Megadyne Recalls E-Z Clean Laparoscopic Electrodes Due to Insulation Breach
Megadyne Medical Products is recalling specific lots of E-Z Clean Disposable Laparoscopic Electrodes due to potential insulation breaches.
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the text, the potential for electrical injury due to insulation breach in a surgical device warrants a high severity rating consistent with Class II classification.
Plain-English summary
Megadyne Medical Products, Inc. is recalling certain lots of E-Z Clean Disposable Laparoscopic Electrodes, Model Numbers 0100L and 0100LS. The affected units have expiration dates ranging from May 2018 to July 2018 and are packaged in sterile chevron Tyvek-polyester peel pouches. The specific lot numbers involved are 131508, 131945, 132167, and 132396 for Model 0100L, and 131509, 131946, and 132058 for Model 0100LS.
The recall was initiated due to a potential breach of the device's insulation. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. A breach in insulation could compromise the safety of the device during use.
The recall is classified as Class II by the FDA and involves worldwide distribution, including the United States. Within the US, the affected units were distributed in California, Hawaii, Illinois, Minnesota, North Carolina, New Jersey, Ohio, Pennsylvania, Texas, Utah, and Virginia. A total of 1,816 units are involved in this recall. Healthcare facilities and distributors should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is
- Manufacturer
- Megadyne Medical Products, Inc.
- Affected units
- 1,816
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 (8)
- Model: 0100L
- Lots: 131508
- 131945
- 132167
- 132396 Model: 0100LS
- Lots: 131509
- 131946
- 132058
Distribution
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