One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
This recall has been terminated (originally issued December 10, 2015).
- Company
- Boston Scientific Corp
- Recall Initiated
- September 11, 2015
- Posted
- December 10, 2015
- Terminated
- May 17, 2016
- Recall Number
- Z-0402-2016
- Quantity
- 22 units
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button.
Distribution
US Distribution to the states of : IN, NV, CA, PA, CT, TN, NY, WI, and WA, and Internationally to Ireland.
Lot / Code Info
Material Number (UPN) M00563020, Lot # 18184947, Exp. April 30, 2017; Material Number M00563080, Lot # 18179867, Exp. April 30, 2017; & Lot # 18212410 , Exp. May 31, 2017; Material Number M00568510, Lot # 18296155, Exp. May 31, 2018.
Root Cause
Under Investigation by firm
Action Taken
Boston Scientific Corp. sent an "Urgent Medical Device Recall Removal - Immediate Action Required" letter dated September 10, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you identify any product from the affected lot within your inventory, please segregate the affected product immediately and return it to Boston Scientific in accordance with the enclosed recall instructions. You will receive replacements for all recalled product that is returned to Boston Scientific. If you are a distributor, or hospital please note that this recall is to the customer level. Please notify any customer who has received affected product. We are notifying affected worldwide regulatory authorities of this Recall Removal as required. Please read carefully through the enclosed Recall Removal Instructions. Your local Sales Representative can answer any questions that you may have regarding this Recall Removal. We regret any inconvenience that this action may cause, and we appreciate your understanding as we take action to ensure patient safety and customer satisfaction. We are committed to continuing to offer products that meet the highest quality standards that you expect from Boston Scientific. Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to Boston Scientific by calling 1-866-868-4004.