Reported Mar 10, 2021 · Ongoing
Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN
5 of 5 products
| # | Product as published |
|---|---|
| 1 | M00561191 (Box 10), M00561190 |
| 2 | M00561221 (Box 10), M00561220 |
| 3 | M00561222 (Box 20), M00561220 |
| 4 | M00561223 (Box 40), M00561220 |
| 5 | M00561233 (Box 40), M00561230. |
- Lot codes and dates
- Outer box GTIN08714729855934
- Inner pouch GTIN08714729861263 Lot/Batch#: 25053639
- Outer box GTIN08714729855903
- Inner pouch GTIN
08714729861294 Lot/Batch#: 2494840724670592246796192467692924939628
- Outer box GTIN08714729861300
- Inner pouch GTIN
087147298 61294 Lot/Batch#: 247703252495255224665104
- Outer box GTIN08714729861317
- Inner pouch GTIN
08714729861294 Lot/Batch#: 2467961425054403
- Outer box GTIN08714729861348
- Inner pouch GTIN08714729861324 Lot/Batch#: 24772995
- Amount recalled
- 335,788 units total (Domestic: 222,882, Foreign: 112,906)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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