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U.S. Department of Health and Human Services

Class 2 Device Recall Anspach Irrigation Clip 40

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  Class 2 Device Recall Anspach Irrigation Clip 40 see related information
Date Initiated by Firm December 03, 2013
Date Posted May 16, 2014
Recall Status1 Terminated 3 on April 18, 2016
Recall Number Z-1629-2014
Recall Event ID 68021
510(K)Number K030576  
Product Classification Pump, infusion - Product Code FRN
Product Anspach Irrigation Clip 40

Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.
Code Information Batch G323082757.
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Suzanne Goodman
561-494-3706
Manufacturer Reason
for Recall		 The Irrigation Clips were assembled with the incorrect (smaller) clips.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action The firm, Anspach, sent an URGENT: Medical Device Removal letter dated December 3, 2013 to its customer. The letter described the product, problem and actions to be taken. Should you have any queries, please do not hesitate to contact Aspach Customer Support at (800) 327-6887.
Quantity in Commerce 150
Distribution US Nationwide Distribution in the state of Mississippi.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = THE ANSPACH EFFORT, INC.
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