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Dreamtome RX 44 recallZ-0751-2022 · Boston Scientific Corporation · initiated Dec 22, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Sterility of device is compromised due to a sterile barrier breach

FDA root cause category: Packaging process control

What the company is doing

BSC issued Urgent Medical Device Product Removal - Immediate Action Required on December 16, 2021. Letter states reason for recall, health risk and action to take: The Reply Verification Tracking Form enclosed with this letter must be completed and returned even if you do not have any product from the affected lot/batches. 1. Immediately discontinue use of and segregate affected product. " Immediately remove all affected product from your inventory. " Segregate this product in a secure location for return to Boston Scientific. 2. You must complete and email or fax your Reply Verification Tracking Form(s) immediately to get an RGA # before you return any product. " Indicate on your RVTF the quantity of units from each lot/batch that you will be returning. " Return the RVTF as described below: Email: [email protected] or Fax to: Field Action Center 1-866-213-1806 You will be contacted by Boston Scientific and provided a Returned Goods Authorization (RGA) Number within 24-48 hours after your RVTF is received " Report all inventory to be returned and report in single-unit quantity(ies), not boxes. " NOTE: If you have responded to this Removal to anyone other than Boston Scientific, we would not have received your response. Please respond using the email/fax information provided above. Credits will be issued for all affected product that is properly returned to Boston Scientific. 3. Package/Ship the Affected Product. " Package any product that is being returned in an appropriate shipping box. " Affix the enclosed (red/white) return address label to the outside of the box. " Write the RGA number in large print on the outside of the box, on the return address label. " Feel free to use our Federal Express Number 9205-2515-6 to return this package via second day delivery. " Seal the box, and return to: Boston Scientific Corporation US Distribution Center Boston Scientific Marina Bay Customer Fulfillment Center 500 Commander Shea Blvd. Quincy, Massachusetts 0217

Recall details

Recall number
Z-0751-2022
Status
Open, Classified
Initiated by the company
Dec 22, 2021
Recalling firm
Boston Scientific Corporation
Quantity
21309 units
Product code
KNS
FDA submissions
K013153
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

Product description

Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040

Code information (models, lots, serial numbers)

Batch Numbers: 27446479 27448337 27470857 27473288 27479007 27488955 27519099 27583248 27584920 27609359 27610230 27616517 27674795 27679150 27681372 27682823 27710650 27715915 27740170 27742966 27746783 27747640 27770749 27779090 27781488 27784284 27806906 27808089 27813903 27818805 27869283 27872956 27955178 27958586 27965294 28021413 28054973 28118052 28296777 28296779 GTIN: 8714729778264

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 89468).

Sources and updates

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