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Class 2 Device Recall Captivator II SingleUse Polypectomy Snares |
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Date Initiated by Firm |
January 19, 2021 |
Create Date |
March 04, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1169-2021 |
Recall Event ID |
87221 |
510(K)Number |
K133987
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Product Classification |
Snare, flexible - Product Code FDI
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Product |
Captivator II Single-Use Polypectomy Snares
Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230. |
Code Information |
Outer box GTIN: 08714729855934 Inner pouch GTIN: 08714729861263 Lot/Batch#: 25053639 Outer box GTIN: 08714729855903 Inner pouch GTIN: 08714729861294 Lot/Batch#: 24948407, 24670592, 24679619, 24676929, 24939628 Outer box GTIN: 08714729861300 Inner pouch GTIN: 087147298 61294 Lot/Batch#: 24770325, 24952552, 24665104 Outer box GTIN: 08714729861317 Inner pouch GTIN: 08714729861294 Lot/Batch#: 24679614, 25054403 Outer box GTIN: 08714729861348 Inner pouch GTIN: 08714729861324 Lot/Batch#: 24772995 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 100 Boston Scientific Way Marlborough MA 01752-1234
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For Additional Information Contact |
Nicole Pshon 763-494-1133
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Manufacturer Reason for Recall |
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
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FDA Determined Cause 2 |
Process change control |
Action |
On 01/21/2021, Boston Scientific issued Urgent Medical Device Product Removal notices to customers via e-mail. The removal notice is due to an incomplete seal of the inner pouch which could result in a sterile barrier breach rendering the specified lots of polypectomy snare devices non-sterile. |
Quantity in Commerce |
335,788 units total (Domestic: 222,882, Foreign: 112,906) |
Distribution |
US nationwide distribution. |
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 = FDI and Original Applicant = Boston Scientific Corporation
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