Recalls / —

—#191836

Product

HYDRATOME RX 44-30MM/450CM Material Number: M00583070

FDA product code

KNS — Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K013153

Affected lot / code info

Lot Numbers: Batch 27556713 27684748 27949033 GTIN: 8714729755227

Why it was recalled

Sterility of device is compromised due to a sterile barrier breach

Root cause (FDA determination)

Packaging process control

Action the firm took

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: BSCFieldActionCenter@bsci.com 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

Recalling firm

Firm

Boston Scientific Corporation

Address

100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2021-12-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #191836. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.