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U.S. Department of Health and Human Services

Class 2 Device Recall Captivator SingleUse Polypectomy Snares, Captiflex SingleUse Polypectomy Snares

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  Class 2 Device Recall Captivator SingleUse Polypectomy Snares, Captiflex SingleUse Polypectomy Snares see related information
Date Initiated by Firm January 19, 2021
Create Date March 04, 2021
Recall Status1 Open3, Classified
Recall Number Z-1168-2021
Recall Event ID 87221
510(K)Number K202478  
Product Classification Snare, flexible - Product Code FDI
Product Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares.

Outer box UPN, Inner Pouch UPN:
M00561311 (Box 10), M00561310
M00562301 (Box 10), M00562300;
M00562321 (Box 10), M00562320;
M00562341 (Box 10), M00562340;
M00562451 (Box 10), M00562450;
M00562401 (Box 10), M00562400;
M00562402 (Box 40), M00562400;
M00562422 (Box 40), M00562420;
M00562471 (Box 10), M00562470.
Code Information Outer box GTIN: 08714729019251 Inner pouch GTIN: 08714729747680 Lot/Batch#: 24725319, 24782695,   Outer box GTIN: 08714729019312 Inner pouch GTIN: 08714729747833 Lot/Batch#: 24842597, 24812577,   Outer box GTIN: 08714729019336 Inner pouch GTIN: 08714729747857 Lot/Batch#: 24889757, 24719202, 24709536, 24773287,   Outer box GTIN: 08714729019350 Inner pouch GTIN: 08714729747871 Lot/Batch#: 24782693, 24732964, 24889755, 24780939,   Outer box GTIN: 08714729071068 Inner pouch GTIN: 08714729747970 Lot/Batch#: 24882357, 24782689, 24782687, 24729758,   Outer box GTIN: 08714729019411 Inner pouch GTIN:08714729747932 Lot/Batch#: 24961643  Outer box GTIN:08714729501640 Inner pouch GTIN: 08714729747932 Lot/Batch#: 24961645, 24989260, 24844193,   Outer box GTIN:08714729501657 Inner pouch GTIN:08714729747956 Lot/Batch#: 25010054,   Outer box GTIN:08714729019459 Inner pouch GTIN:08714729747994 Lot/Batch#: 25016793.
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Nicole Pshon
763-494-1133
Manufacturer Reason
for Recall		 Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
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
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.
510(K) Database 510(K)s with Product Code = FDI and Original Applicant = Boston Scientific Corporation
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