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Class 2 Device Recall ROTAWIRE |
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Date Initiated by Firm |
March 08, 2022 |
Create Date |
April 12, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0915-2022 |
Recall Event ID |
89753 |
PMA Number |
P900056 |
Product Classification |
Catheter, coronary, atherectomy - Product Code MCX
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Product |
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy |
Code Information |
ROTAWIRE Drive Floppy, 5 pack, UPN: H74939462005
Individual units within 5-pack are labeled as Single, UPN: H74939462001
Batch numbers: 27622475, 27622478, 27691111, 27698472, 27706785, 27708190, 27756019
27756205, 27756933, and 27756935
GTIN: 08714729996255 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Scimed Pl Maple Grove MN 55311-1565
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For Additional Information Contact |
Rebecca Kinkead Rubio 763-494-1133
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Manufacturer Reason for Recall |
Pouch seals may be open, compromising sterility.
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FDA Determined Cause 2 |
Process control |
Action |
US consignees were mailed an overnight delivery of the customer letter. OUS consignees will be contacted by letter delivery or email.
Accounts are asked to return any unused affected devices to the recalling firm. The customer letter provides customers with the product segregation and return instructions and accounts are asked to complete a Reply Verification Tracking Form indicating that they have received the field removal and followed the included instructions. |
Quantity in Commerce |
433 5-packs |
Distribution |
Distribution in the US and territories, Japan, and Canada |
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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PMA Database |
PMAs with Product Code = MCX and Original Applicant = Boston Scientific Corp.
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