| | Class 2 Device Recall Boston Scientific |  |
| Date Initiated by Firm | December 22, 2021 |
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| Create Date | March 11, 2022 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0781-2022 |
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| Recall Event ID |
89468 |
| 510(K)Number | K013153 |
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| Product Classification |
Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
|
| Product | RX CHOLANGIOGRAM KIT - SINGLE
Material Number:
M00575240
M00575240
M00575280
M00575320
M00575360
M00575380
M00575400
M00575440
M00575480 |
|---|
| Code Information |
Lot Numbers/UDI:
27877022 8714729750031
28098229 8714729750031
28329450 8714729750031
27803952 8714729750079
27877021 8714729750079
27914711 8714729750079
27950226 8714729750079
28110693 8714729750079
27950225 8714729750116
28018192 8714729750116
28253295 8714729750116
28069582 8714729750154
27751896 8714729750178
27983611 8714729750178
28296770 8714729750192
27658435 8714729750239
27891175 8714729750239
28018195 8714729750239
27914712 8714729750277
|
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
|
| For Additional Information Contact | Brendan Smith
508-683-4000 |
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Manufacturer Reason
for Recall | Sterility of device is compromised due to a sterile barrier breach |
|---|
FDA Determined
Cause 2 | Packaging process control |
|---|
| Action | 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 |
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| 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.
|
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = KNS
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