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U.S. Department of Health and Human Services

Class 2 Device Recall BIB PTA Catheter

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 Class 2 Device Recall BIB PTA Cathetersee related information
Date Initiated by FirmApril 21, 2025
Date PostedMay 13, 2025
Recall Status1 Terminated 3 on December 17, 2025
Recall NumberZ-1754-2025
Recall Event ID 96734
510(K)NumberK050857 
Product Classification Catheter, angioplasty, peripheral, transluminal, dual-balloon - Product Code NVM
ProductBIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Code Information Model Number 420. UDI-DI: 04046964899768. Lot Numbers: BIB-16972 (Expiration date: 11/30/2028), BIB-16972-1 (Expiration date: 12/31/2028). Catheter Product Code: BB005.
FEI Number 1318694
Recalling Firm/
Manufacturer		 Numed Inc
2880 Main Street /Rt 11b
Hopkinton NY 12965
For Additional Information Contact
315-328-4491
Manufacturer Reason
for Recall		Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionNuMED sent a "URGENT: MEDICAL DEVICE RECALL" letter dated 4/21/2025 via email on 4/21/2025 to their single customer. The customer was instructed to immediately return the affected units as soon as possible. If you have any questions or concerns, please contact Regulatory Affairs Manager at (315) 328-4491, or via email at nlaflesh@numedusa.com.
Quantity in Commerce4 units
DistributionUS distribution to Pennsylvania.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NVM
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