Z-0781-2022Class II

RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380...

Name: Z-0781-2022 RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380...
Creator: Boston Scientific Corporation
Published: 2021-12-22
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2021-12-22 / Open, Classified / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480 on 2021-12-22. FDA classified it as Class II and gives the reason as "Sterility of device is compromised due to a sterile barrier breach". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0781-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-22
Posted: 2022-03-11
Recalling firm: Boston Scientific Corporation
Product: RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Reason for recall: Sterility of device is compromised due to a sterile barrier breach
Root cause tag: packaging
FDA root cause: 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: [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
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0781-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0751-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0752-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0753-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0754-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0755-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0756-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0757-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0758-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0759-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0760-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0761-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0762-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0763-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0764-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0765-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0766-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0767-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0768-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0769-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0770-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0771-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0772-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0773-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0774-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0775-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0776-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0777-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0778-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0779-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0780-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0781-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11

Product code KNS

K013153Class IIAutotome Rx Model # 4515, 4516Boston Scientific Corp / cleared 2001-10-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)