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U.S. Department of Health and Human Services

Class 2 Device Recall Reprocessed Agilis Steerable Introducer

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 Class 2 Device Recall Reprocessed Agilis Steerable Introducersee related information
Date Initiated by FirmSeptember 17, 2018
Date PostedOctober 09, 2018
Recall Status1 Terminated 3 on August 04, 2020
Recall NumberZ-0090-2019
Recall Event ID 80999
510(K)NumberK152090 
Product Classification Stomach suturing device for weight loss - Product Code PNH
ProductReprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324
Code Information All lots with expiration dates prior to 2019-06-08 of the following: (a) Product Code STJ408309, GTIN 10888551044912  (b) Product Code STJ408310, GTIN 10888551044929 (c) Product Code STJ408324, GTIN 10888551044950 
FEI Number 3011276773
Recalling Firm/
Manufacturer		 Sterilmed, Inc.
5010 Cheshire Pkwy N Ste 2
Plymouth MN 55446-4101
Manufacturer Reason
for Recall		Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
FDA Determined
Cause 2		Material/Component Contamination
ActionSterilmed notified customers on about 09/17/2018, via URGENT MEDICAL DEVICE RECALL letter sent via UPS next day. Instructions included examine inventory for affected devices, remove and return affected devices to Stericycle (3rd party processor), provide recall information to appropriate personnel at the facility, and complete and return the Business Reply Form to Stericycle. For questions, contact Sterilmed's Customer Care Team at (888) 541-0078, Monday through Friday from 7:00 AM to 5:00 PM CST.
Quantity in Commerce218 units
DistributionU.S. Nationwide distribution in the states of CA, CO, MN, and WA.
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 = PNH
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