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Class 2 Device Recall Captivator/Captiflex/Sensation Short Throw 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-1170-2021 |
Recall Event ID |
87221 |
510(K)Number |
K131700
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Product Classification |
Snare, flexible - Product Code FDI
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Product |
Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares
Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (Box 20), M00562650; M00562671 (Box 5), M00562670; M00562672 (Box 20), M00562670; M00562673 (Box 40), M00562670; M00562691 (Box 5); M00562690; M00562692 (Box 20), M00562690; M00562693 (Box 40), M00562690. |
Code Information |
Outer box GTIN: 08714729283904 Inner pouch GTIN: 08714729747598 Lot/Batch#: 24818278, 24906823, 25042455 Outer box GTIN: 08714729283928 Inner pouch GTIN: 08714729747611 Lot/Batch#: 24685766, 24817145, 24899710, 24739786, 25006735, 24861901 Outer box GTIN: 08714729158110 Inner pouch GTIN: 08714729748069 Lot/Batch#: 24685764, 24890051, 24824132 Outer box GTIN: 08714729268802 Inner pouch GTIN: 08714729748069 Lot/Batch#: 25023345 Outer box GTIN: 08714729158141 Inner pouch GTIN: 08714729748083 Lot/Batch#: 24699718, 24939626, 24861739 Outer box GTIN: 08714729268819 Inner pouch GTIN: 08714729748083 Lot/Batch#: 24824134, 25006729, 24709534 Outer box GTIN: 08714729501664 Inner pouch GTIN: 08714729748083 Lot/Batch#: 25023203, 24697822, 24739587, 24942292, 24909214, 24824136 Outer box GTIN: 08714729158158 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24856636, 24927642, 24699218 Outer box GTIN: 08714729268826 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24835709, 24818605, 25023343 Outer box GTIN: 08714729501671 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24909216, 24758832, 24872119, 24994171, 25048397, 2475126, 24929431, 24995438 |
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 CORP.
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