Boston Scientific Recalls One Step Button PEG Kits Due to Adapter Defect
Boston Scientific is voluntarily recalling specific lots of One Step Button PEG kits because a protrusion on the decompression tube adapter may prevent the device from being inserted or removed.
What this means for you
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 defect that could impede the insertion or removal of a gastro-enterostomy tube, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Boston Scientific Corp. has initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices. The recall is due to a defect where the decompression tube adapters may contain a protrusion that could impede the ability to introduce or remove the adapter from the PEG Button.
The affected products are distributed in the United States to the states of Indiana, Nevada, California, Pennsylvania, Connecticut, Tennessee, New York, Wisconsin, and Washington, as well as internationally to Ireland. The recall covers 22 units across four specific material numbers and lot combinations with expiration dates ranging from April 30, 2017, to May 31, 2018.
Healthcare providers and patients who have received these specific lots should contact Boston Scientific for instructions on how to manage the device or obtain a replacement. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
- Manufacturer
- Boston Scientific Corp
- Affected units
- 22
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 (12)
- Material Number (UPN) M00563020
- Lot # 18184947
- Exp. April 30
- 2017
- Material Number M00563080
- Lot # 18179867
- Exp. April 30
- & Lot # 18212410
- Exp. May 31
- Material Number M00568510
- Lot # 18296155
- 2018.
Distribution
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