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U.S. Department of Health and Human Services

Class 2 Device Recall Flexima APDL Drainage Catheter System and Kit

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 Class 2 Device Recall Flexima APDL Drainage Catheter System and Kitsee related information
Date Initiated by FirmJuly 18, 2024
Date PostedSeptember 13, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3147-2024
Recall Event ID 95186
510(K)NumberK211934 
Product Classification Tube, drainage, suprapubic - Product Code FFA
ProductFlexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
Code Information a) GTIN/UDI 0871472932347, Lot # 33540319, Exp. 03/01/2027; b) GTIN/UDI 0871472932348, Lot # 33471466, Exp. 02/21/2027
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information ContactRebecca KinKead Rubio
763-494-1133
Manufacturer Reason
for Recall		There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
FDA Determined
Cause 2		Packaging process control
ActionBoston Scientific issued am Urgent Medical Device Removal notice to it consignees on 07/18/2024 via overnight mail. The notice explained the issue, potential hazard, and requested the return of the devices. Consignees were directed to post the notice in a visible location near the affected products to ensure visibility and to share the notice with all those to whom the device was transferred. Distributors were direct to notify their customers.
Quantity in Commerce89 units
DistributionUS, Colombia, Philippines, Russia
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FFA
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